Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study
Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact...
Gespeichert in:
| Veröffentlicht in: | Lancet neurology 2020-06, Vol.19 (6), p.491-501 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 501 |
|---|---|
| container_issue | 6 |
| container_start_page | 491 |
| container_title | Lancet neurology |
| container_volume | 19 |
| creator | Vitek, Jerrold L Jain, Roshini Chen, Lilly Tröster, Alexander I Schrock, Lauren E House, Paul A Giroux, Monique L Hebb, Adam O Farris, Sierra M Whiting, Donald M Leichliter, Timothy A Ostrem, Jill L San Luciano, Marta Galifianakis, Nicholas Verhagen Metman, Leo Sani, Sepehr Karl, Jessica A Siddiqui, Mustafa S Tatter, Stephen B ul Haq, Ihtsham Machado, Andre G Gostkowski, Michal Tagliati, Michele Mamelak, Adam N Okun, Michael S Foote, Kelly D Moguel-Cobos, Guillermo Ponce, Francisco A Pahwa, Rajesh Nazzaro, Jules M Buetefisch, Cathrin M Gross, Robert E Luca, Corneliu C Jagid, Jonathan R Revuelta, Gonzalo J Takacs, Istvan Pourfar, Michael H Mogilner, Alon Y Duker, Andrew P Mandybur, George T Rosenow, Joshua M Cooper, Scott E Park, Michael C Khandhar, Suketu M Sedrak, Mark Phibbs, Fenna T Pilitsis, Julie G Uitti, Ryan J Starr, Philip A |
| description | Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.
This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.
Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (p |
| doi_str_mv | 10.1016/S1474-4422(20)30108-3 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2408205972</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1474442220301083</els_id><sourcerecordid>2424890477</sourcerecordid><originalsourceid>FETCH-LOGICAL-c393t-a01e10fecaf7c71ee56b581286b7c6e334e1a13011c589d64c5d71fc646260613</originalsourceid><addsrcrecordid>eNqFkd1u1DAQhSMEoj_wCCBLXLCVGrAdx8lyg6pSYKUKKlquLceeaF0cO_inqM_IS-HtbivEDTf2ePTNOSOfqnpB8BuCCX97SVjHasYoXVB81GCC-7p5VO3v2rx9_FBTulcdxHiNMSWsJ0-rvYayDjNK9qvfl3lIa2nlZBRyWVnIEWmAGQ1BGodiMlO2Mhnv0C-T1kii8k5mtoCM0zBDOVxCyruY5KbIIZRGXRopeGtBF7kbozY4upDhh3HRu9fFxESQEdBi9eXq29nF6sPRu3txVQQCHCPt82ChHmxxOkZBOu2nMlXquJbT3xYxZX37rHoyShvh-e4-rL5_PLs6_Vyff_20Oj05r1WzbFItMQGCR1By7FRHAFo-tD2hPR86xaFpGBBJyo8S1fZLzZlqdUdGxRmnHHPSHFaLre4c_M8MMYmylQJrpQOfo6AM9xS3y44W9NU_6LXPwZXtCkVZv8Ss6wrVbikVfIwBRjEHM8lwKwgWm7TFXdpiE6WgWNylLZoy93KnnocJ9MPUfbwFeL8FoHzHjYEgojLgFGgTQCWhvfmPxR92e7yy</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2424890477</pqid></control><display><type>article</type><title>Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study</title><source>ScienceDirect Journals (5 years ago - present)</source><source>ProQuest Central UK/Ireland</source><creator>Vitek, Jerrold L ; Jain, Roshini ; Chen, Lilly ; Tröster, Alexander I ; Schrock, Lauren E ; House, Paul A ; Giroux, Monique L ; Hebb, Adam O ; Farris, Sierra M ; Whiting, Donald M ; Leichliter, Timothy A ; Ostrem, Jill L ; San Luciano, Marta ; Galifianakis, Nicholas ; Verhagen Metman, Leo ; Sani, Sepehr ; Karl, Jessica A ; Siddiqui, Mustafa S ; Tatter, Stephen B ; ul Haq, Ihtsham ; Machado, Andre G ; Gostkowski, Michal ; Tagliati, Michele ; Mamelak, Adam N ; Okun, Michael S ; Foote, Kelly D ; Moguel-Cobos, Guillermo ; Ponce, Francisco A ; Pahwa, Rajesh ; Nazzaro, Jules M ; Buetefisch, Cathrin M ; Gross, Robert E ; Luca, Corneliu C ; Jagid, Jonathan R ; Revuelta, Gonzalo J ; Takacs, Istvan ; Pourfar, Michael H ; Mogilner, Alon Y ; Duker, Andrew P ; Mandybur, George T ; Rosenow, Joshua M ; Cooper, Scott E ; Park, Michael C ; Khandhar, Suketu M ; Sedrak, Mark ; Phibbs, Fenna T ; Pilitsis, Julie G ; Uitti, Ryan J ; Starr, Philip A</creator><creatorcontrib>Vitek, Jerrold L ; Jain, Roshini ; Chen, Lilly ; Tröster, Alexander I ; Schrock, Lauren E ; House, Paul A ; Giroux, Monique L ; Hebb, Adam O ; Farris, Sierra M ; Whiting, Donald M ; Leichliter, Timothy A ; Ostrem, Jill L ; San Luciano, Marta ; Galifianakis, Nicholas ; Verhagen Metman, Leo ; Sani, Sepehr ; Karl, Jessica A ; Siddiqui, Mustafa S ; Tatter, Stephen B ; ul Haq, Ihtsham ; Machado, Andre G ; Gostkowski, Michal ; Tagliati, Michele ; Mamelak, Adam N ; Okun, Michael S ; Foote, Kelly D ; Moguel-Cobos, Guillermo ; Ponce, Francisco A ; Pahwa, Rajesh ; Nazzaro, Jules M ; Buetefisch, Cathrin M ; Gross, Robert E ; Luca, Corneliu C ; Jagid, Jonathan R ; Revuelta, Gonzalo J ; Takacs, Istvan ; Pourfar, Michael H ; Mogilner, Alon Y ; Duker, Andrew P ; Mandybur, George T ; Rosenow, Joshua M ; Cooper, Scott E ; Park, Michael C ; Khandhar, Suketu M ; Sedrak, Mark ; Phibbs, Fenna T ; Pilitsis, Julie G ; Uitti, Ryan J ; Starr, Philip A</creatorcontrib><description>Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.
This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.
Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3–4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes.
Boston Scientific.</description><identifier>ISSN: 1474-4422</identifier><identifier>EISSN: 1474-4465</identifier><identifier>DOI: 10.1016/S1474-4422(20)30108-3</identifier><identifier>PMID: 32470421</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Basal ganglia ; Batteries ; Central nervous system diseases ; Clinical outcomes ; Clinical trials ; Deep brain stimulation ; Double-blind studies ; Electrical stimuli ; Medical treatment ; Movement disorders ; Neurodegenerative diseases ; Parkinson's disease ; Patients ; Quality of life ; Questionnaires ; Subthalamic nucleus ; Suicides & suicide attempts ; Transplants & implants</subject><ispartof>Lancet neurology, 2020-06, Vol.19 (6), p.491-501</ispartof><rights>2020 Elsevier Ltd</rights><rights>Copyright © 2020 Elsevier Ltd. All rights reserved.</rights><rights>2020. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-a01e10fecaf7c71ee56b581286b7c6e334e1a13011c589d64c5d71fc646260613</citedby><cites>FETCH-LOGICAL-c393t-a01e10fecaf7c71ee56b581286b7c6e334e1a13011c589d64c5d71fc646260613</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2424890477?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3548,27922,27923,45993,64383,64385,64387,72239</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32470421$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vitek, Jerrold L</creatorcontrib><creatorcontrib>Jain, Roshini</creatorcontrib><creatorcontrib>Chen, Lilly</creatorcontrib><creatorcontrib>Tröster, Alexander I</creatorcontrib><creatorcontrib>Schrock, Lauren E</creatorcontrib><creatorcontrib>House, Paul A</creatorcontrib><creatorcontrib>Giroux, Monique L</creatorcontrib><creatorcontrib>Hebb, Adam O</creatorcontrib><creatorcontrib>Farris, Sierra M</creatorcontrib><creatorcontrib>Whiting, Donald M</creatorcontrib><creatorcontrib>Leichliter, Timothy A</creatorcontrib><creatorcontrib>Ostrem, Jill L</creatorcontrib><creatorcontrib>San Luciano, Marta</creatorcontrib><creatorcontrib>Galifianakis, Nicholas</creatorcontrib><creatorcontrib>Verhagen Metman, Leo</creatorcontrib><creatorcontrib>Sani, Sepehr</creatorcontrib><creatorcontrib>Karl, Jessica A</creatorcontrib><creatorcontrib>Siddiqui, Mustafa S</creatorcontrib><creatorcontrib>Tatter, Stephen B</creatorcontrib><creatorcontrib>ul Haq, Ihtsham</creatorcontrib><creatorcontrib>Machado, Andre G</creatorcontrib><creatorcontrib>Gostkowski, Michal</creatorcontrib><creatorcontrib>Tagliati, Michele</creatorcontrib><creatorcontrib>Mamelak, Adam N</creatorcontrib><creatorcontrib>Okun, Michael S</creatorcontrib><creatorcontrib>Foote, Kelly D</creatorcontrib><creatorcontrib>Moguel-Cobos, Guillermo</creatorcontrib><creatorcontrib>Ponce, Francisco A</creatorcontrib><creatorcontrib>Pahwa, Rajesh</creatorcontrib><creatorcontrib>Nazzaro, Jules M</creatorcontrib><creatorcontrib>Buetefisch, Cathrin M</creatorcontrib><creatorcontrib>Gross, Robert E</creatorcontrib><creatorcontrib>Luca, Corneliu C</creatorcontrib><creatorcontrib>Jagid, Jonathan R</creatorcontrib><creatorcontrib>Revuelta, Gonzalo J</creatorcontrib><creatorcontrib>Takacs, Istvan</creatorcontrib><creatorcontrib>Pourfar, Michael H</creatorcontrib><creatorcontrib>Mogilner, Alon Y</creatorcontrib><creatorcontrib>Duker, Andrew P</creatorcontrib><creatorcontrib>Mandybur, George T</creatorcontrib><creatorcontrib>Rosenow, Joshua M</creatorcontrib><creatorcontrib>Cooper, Scott E</creatorcontrib><creatorcontrib>Park, Michael C</creatorcontrib><creatorcontrib>Khandhar, Suketu M</creatorcontrib><creatorcontrib>Sedrak, Mark</creatorcontrib><creatorcontrib>Phibbs, Fenna T</creatorcontrib><creatorcontrib>Pilitsis, Julie G</creatorcontrib><creatorcontrib>Uitti, Ryan J</creatorcontrib><creatorcontrib>Starr, Philip A</creatorcontrib><title>Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study</title><title>Lancet neurology</title><addtitle>Lancet Neurol</addtitle><description>Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.
This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.
Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3–4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes.
Boston Scientific.</description><subject>Basal ganglia</subject><subject>Batteries</subject><subject>Central nervous system diseases</subject><subject>Clinical outcomes</subject><subject>Clinical trials</subject><subject>Deep brain stimulation</subject><subject>Double-blind studies</subject><subject>Electrical stimuli</subject><subject>Medical treatment</subject><subject>Movement disorders</subject><subject>Neurodegenerative diseases</subject><subject>Parkinson's disease</subject><subject>Patients</subject><subject>Quality of life</subject><subject>Questionnaires</subject><subject>Subthalamic nucleus</subject><subject>Suicides & suicide attempts</subject><subject>Transplants & implants</subject><issn>1474-4422</issn><issn>1474-4465</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqFkd1u1DAQhSMEoj_wCCBLXLCVGrAdx8lyg6pSYKUKKlquLceeaF0cO_inqM_IS-HtbivEDTf2ePTNOSOfqnpB8BuCCX97SVjHasYoXVB81GCC-7p5VO3v2rx9_FBTulcdxHiNMSWsJ0-rvYayDjNK9qvfl3lIa2nlZBRyWVnIEWmAGQ1BGodiMlO2Mhnv0C-T1kii8k5mtoCM0zBDOVxCyruY5KbIIZRGXRopeGtBF7kbozY4upDhh3HRu9fFxESQEdBi9eXq29nF6sPRu3txVQQCHCPt82ChHmxxOkZBOu2nMlXquJbT3xYxZX37rHoyShvh-e4-rL5_PLs6_Vyff_20Oj05r1WzbFItMQGCR1By7FRHAFo-tD2hPR86xaFpGBBJyo8S1fZLzZlqdUdGxRmnHHPSHFaLre4c_M8MMYmylQJrpQOfo6AM9xS3y44W9NU_6LXPwZXtCkVZv8Ss6wrVbikVfIwBRjEHM8lwKwgWm7TFXdpiE6WgWNylLZoy93KnnocJ9MPUfbwFeL8FoHzHjYEgojLgFGgTQCWhvfmPxR92e7yy</recordid><startdate>202006</startdate><enddate>202006</enddate><creator>Vitek, Jerrold L</creator><creator>Jain, Roshini</creator><creator>Chen, Lilly</creator><creator>Tröster, Alexander I</creator><creator>Schrock, Lauren E</creator><creator>House, Paul A</creator><creator>Giroux, Monique L</creator><creator>Hebb, Adam O</creator><creator>Farris, Sierra M</creator><creator>Whiting, Donald M</creator><creator>Leichliter, Timothy A</creator><creator>Ostrem, Jill L</creator><creator>San Luciano, Marta</creator><creator>Galifianakis, Nicholas</creator><creator>Verhagen Metman, Leo</creator><creator>Sani, Sepehr</creator><creator>Karl, Jessica A</creator><creator>Siddiqui, Mustafa S</creator><creator>Tatter, Stephen B</creator><creator>ul Haq, Ihtsham</creator><creator>Machado, Andre G</creator><creator>Gostkowski, Michal</creator><creator>Tagliati, Michele</creator><creator>Mamelak, Adam N</creator><creator>Okun, Michael S</creator><creator>Foote, Kelly D</creator><creator>Moguel-Cobos, Guillermo</creator><creator>Ponce, Francisco A</creator><creator>Pahwa, Rajesh</creator><creator>Nazzaro, Jules M</creator><creator>Buetefisch, Cathrin M</creator><creator>Gross, Robert E</creator><creator>Luca, Corneliu C</creator><creator>Jagid, Jonathan R</creator><creator>Revuelta, Gonzalo J</creator><creator>Takacs, Istvan</creator><creator>Pourfar, Michael H</creator><creator>Mogilner, Alon Y</creator><creator>Duker, Andrew P</creator><creator>Mandybur, George T</creator><creator>Rosenow, Joshua M</creator><creator>Cooper, Scott E</creator><creator>Park, Michael C</creator><creator>Khandhar, Suketu M</creator><creator>Sedrak, Mark</creator><creator>Phibbs, Fenna T</creator><creator>Pilitsis, Julie G</creator><creator>Uitti, Ryan J</creator><creator>Starr, Philip A</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>0TZ</scope><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8AO</scope><scope>8C2</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>202006</creationdate><title>Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study</title><author>Vitek, Jerrold L ; Jain, Roshini ; Chen, Lilly ; Tröster, Alexander I ; Schrock, Lauren E ; House, Paul A ; Giroux, Monique L ; Hebb, Adam O ; Farris, Sierra M ; Whiting, Donald M ; Leichliter, Timothy A ; Ostrem, Jill L ; San Luciano, Marta ; Galifianakis, Nicholas ; Verhagen Metman, Leo ; Sani, Sepehr ; Karl, Jessica A ; Siddiqui, Mustafa S ; Tatter, Stephen B ; ul Haq, Ihtsham ; Machado, Andre G ; Gostkowski, Michal ; Tagliati, Michele ; Mamelak, Adam N ; Okun, Michael S ; Foote, Kelly D ; Moguel-Cobos, Guillermo ; Ponce, Francisco A ; Pahwa, Rajesh ; Nazzaro, Jules M ; Buetefisch, Cathrin M ; Gross, Robert E ; Luca, Corneliu C ; Jagid, Jonathan R ; Revuelta, Gonzalo J ; Takacs, Istvan ; Pourfar, Michael H ; Mogilner, Alon Y ; Duker, Andrew P ; Mandybur, George T ; Rosenow, Joshua M ; Cooper, Scott E ; Park, Michael C ; Khandhar, Suketu M ; Sedrak, Mark ; Phibbs, Fenna T ; Pilitsis, Julie G ; Uitti, Ryan J ; Starr, Philip A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-a01e10fecaf7c71ee56b581286b7c6e334e1a13011c589d64c5d71fc646260613</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Basal ganglia</topic><topic>Batteries</topic><topic>Central nervous system diseases</topic><topic>Clinical outcomes</topic><topic>Clinical trials</topic><topic>Deep brain stimulation</topic><topic>Double-blind studies</topic><topic>Electrical stimuli</topic><topic>Medical treatment</topic><topic>Movement disorders</topic><topic>Neurodegenerative diseases</topic><topic>Parkinson's disease</topic><topic>Patients</topic><topic>Quality of life</topic><topic>Questionnaires</topic><topic>Subthalamic nucleus</topic><topic>Suicides & suicide attempts</topic><topic>Transplants & implants</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vitek, Jerrold L</creatorcontrib><creatorcontrib>Jain, Roshini</creatorcontrib><creatorcontrib>Chen, Lilly</creatorcontrib><creatorcontrib>Tröster, Alexander I</creatorcontrib><creatorcontrib>Schrock, Lauren E</creatorcontrib><creatorcontrib>House, Paul A</creatorcontrib><creatorcontrib>Giroux, Monique L</creatorcontrib><creatorcontrib>Hebb, Adam O</creatorcontrib><creatorcontrib>Farris, Sierra M</creatorcontrib><creatorcontrib>Whiting, Donald M</creatorcontrib><creatorcontrib>Leichliter, Timothy A</creatorcontrib><creatorcontrib>Ostrem, Jill L</creatorcontrib><creatorcontrib>San Luciano, Marta</creatorcontrib><creatorcontrib>Galifianakis, Nicholas</creatorcontrib><creatorcontrib>Verhagen Metman, Leo</creatorcontrib><creatorcontrib>Sani, Sepehr</creatorcontrib><creatorcontrib>Karl, Jessica A</creatorcontrib><creatorcontrib>Siddiqui, Mustafa S</creatorcontrib><creatorcontrib>Tatter, Stephen B</creatorcontrib><creatorcontrib>ul Haq, Ihtsham</creatorcontrib><creatorcontrib>Machado, Andre G</creatorcontrib><creatorcontrib>Gostkowski, Michal</creatorcontrib><creatorcontrib>Tagliati, Michele</creatorcontrib><creatorcontrib>Mamelak, Adam N</creatorcontrib><creatorcontrib>Okun, Michael S</creatorcontrib><creatorcontrib>Foote, Kelly D</creatorcontrib><creatorcontrib>Moguel-Cobos, Guillermo</creatorcontrib><creatorcontrib>Ponce, Francisco A</creatorcontrib><creatorcontrib>Pahwa, Rajesh</creatorcontrib><creatorcontrib>Nazzaro, Jules M</creatorcontrib><creatorcontrib>Buetefisch, Cathrin M</creatorcontrib><creatorcontrib>Gross, Robert E</creatorcontrib><creatorcontrib>Luca, Corneliu C</creatorcontrib><creatorcontrib>Jagid, Jonathan R</creatorcontrib><creatorcontrib>Revuelta, Gonzalo J</creatorcontrib><creatorcontrib>Takacs, Istvan</creatorcontrib><creatorcontrib>Pourfar, Michael H</creatorcontrib><creatorcontrib>Mogilner, Alon Y</creatorcontrib><creatorcontrib>Duker, Andrew P</creatorcontrib><creatorcontrib>Mandybur, George T</creatorcontrib><creatorcontrib>Rosenow, Joshua M</creatorcontrib><creatorcontrib>Cooper, Scott E</creatorcontrib><creatorcontrib>Park, Michael C</creatorcontrib><creatorcontrib>Khandhar, Suketu M</creatorcontrib><creatorcontrib>Sedrak, Mark</creatorcontrib><creatorcontrib>Phibbs, Fenna T</creatorcontrib><creatorcontrib>Pilitsis, Julie G</creatorcontrib><creatorcontrib>Uitti, Ryan J</creatorcontrib><creatorcontrib>Starr, Philip A</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Pharma and Biotech Premium PRO</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Neurosciences Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>ProQuest Pharma Collection</collection><collection>Lancet Titles</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Lancet neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vitek, Jerrold L</au><au>Jain, Roshini</au><au>Chen, Lilly</au><au>Tröster, Alexander I</au><au>Schrock, Lauren E</au><au>House, Paul A</au><au>Giroux, Monique L</au><au>Hebb, Adam O</au><au>Farris, Sierra M</au><au>Whiting, Donald M</au><au>Leichliter, Timothy A</au><au>Ostrem, Jill L</au><au>San Luciano, Marta</au><au>Galifianakis, Nicholas</au><au>Verhagen Metman, Leo</au><au>Sani, Sepehr</au><au>Karl, Jessica A</au><au>Siddiqui, Mustafa S</au><au>Tatter, Stephen B</au><au>ul Haq, Ihtsham</au><au>Machado, Andre G</au><au>Gostkowski, Michal</au><au>Tagliati, Michele</au><au>Mamelak, Adam N</au><au>Okun, Michael S</au><au>Foote, Kelly D</au><au>Moguel-Cobos, Guillermo</au><au>Ponce, Francisco A</au><au>Pahwa, Rajesh</au><au>Nazzaro, Jules M</au><au>Buetefisch, Cathrin M</au><au>Gross, Robert E</au><au>Luca, Corneliu C</au><au>Jagid, Jonathan R</au><au>Revuelta, Gonzalo J</au><au>Takacs, Istvan</au><au>Pourfar, Michael H</au><au>Mogilner, Alon Y</au><au>Duker, Andrew P</au><au>Mandybur, George T</au><au>Rosenow, Joshua M</au><au>Cooper, Scott E</au><au>Park, Michael C</au><au>Khandhar, Suketu M</au><au>Sedrak, Mark</au><au>Phibbs, Fenna T</au><au>Pilitsis, Julie G</au><au>Uitti, Ryan J</au><au>Starr, Philip A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study</atitle><jtitle>Lancet neurology</jtitle><addtitle>Lancet Neurol</addtitle><date>2020-06</date><risdate>2020</risdate><volume>19</volume><issue>6</issue><spage>491</spage><epage>501</epage><pages>491-501</pages><issn>1474-4422</issn><eissn>1474-4465</eissn><abstract>Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.
This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.
Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3–4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes.
Boston Scientific.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>32470421</pmid><doi>10.1016/S1474-4422(20)30108-3</doi><tpages>11</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1474-4422 |
| ispartof | Lancet neurology, 2020-06, Vol.19 (6), p.491-501 |
| issn | 1474-4422 1474-4465 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2408205972 |
| source | ScienceDirect Journals (5 years ago - present); ProQuest Central UK/Ireland |
| subjects | Basal ganglia Batteries Central nervous system diseases Clinical outcomes Clinical trials Deep brain stimulation Double-blind studies Electrical stimuli Medical treatment Movement disorders Neurodegenerative diseases Parkinson's disease Patients Quality of life Questionnaires Subthalamic nucleus Suicides & suicide attempts Transplants & implants |
| title | Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-13T13%3A50%3A22IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Subthalamic%20nucleus%20deep%20brain%20stimulation%20with%20a%20multiple%20independent%20constant%20current-controlled%20device%20in%20Parkinson's%20disease%20(INTREPID):%20a%20multicentre,%20double-blind,%20randomised,%20sham-controlled%20study&rft.jtitle=Lancet%20neurology&rft.au=Vitek,%20Jerrold%20L&rft.date=2020-06&rft.volume=19&rft.issue=6&rft.spage=491&rft.epage=501&rft.pages=491-501&rft.issn=1474-4422&rft.eissn=1474-4465&rft_id=info:doi/10.1016/S1474-4422(20)30108-3&rft_dat=%3Cproquest_cross%3E2424890477%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2424890477&rft_id=info:pmid/32470421&rft_els_id=S1474442220301083&rfr_iscdi=true |