Focused ultrasound subthalamotomy in patients with asymmetric Parkinson's disease: a pilot study
Ablative neurosurgery has been used to treat Parkinson's disease for many decades. MRI-guided focused ultrasound allows focal lesions to be made in deep brain structures without skull incision. We investigated the safety and preliminary efficacy of unilateral subthalamotomy by focused ultrasoun...
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| Veröffentlicht in: | Lancet neurology 2018-01, Vol.17 (1), p.54-63 |
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| creator | Martínez-Fernández, Raul Rodríguez-Rojas, Rafael del Álamo, Marta Hernández-Fernández, Frida Pineda-Pardo, Jose A Dileone, Michele Alonso-Frech, Fernando Foffani, Guglielmo Obeso, Ignacio Gasca-Salas, Carmen de Luis-Pastor, Esther Vela, Lydia Obeso, José A |
| description | Ablative neurosurgery has been used to treat Parkinson's disease for many decades. MRI-guided focused ultrasound allows focal lesions to be made in deep brain structures without skull incision. We investigated the safety and preliminary efficacy of unilateral subthalamotomy by focused ultrasound in Parkinson's disease.
This prospective, open-label pilot study was done at CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur in Madrid, Spain. Eligible participants had Parkinson's disease with markedly asymmetric parkinsonism. Patients with severe dyskinesia, history of stereotactic surgery or brain haemorrhage, a diagnosis of an unstable cardiac or psychiatric disease, or a skull density ratio of 0·3 or less were excluded. Enrolled patients underwent focused ultrasound unilateral subthalamotomy. The subthalamic nucleus was targeted by means of brain images acquired with a 3-Tesla MRI apparatus. Several sonications above the definitive ablation temperature of 55°C were delivered and adjusted according to clinical response. The primary outcomes were safety and a change in the motor status of the treated hemibody as assessed with part III of the Movement Disorders Society–Unified Parkinson's Disease Rating Scale (MDS–UPDRS III) in both off-medication and on-medication states at 6 months. Adverse events were monitored up to 48 h after treatment and at scheduled clinic visits at 1, 3, and 6 months after treatment. The study is registered with ClinicalTrials.gov, number NCT02912871.
Between April 26 and June 14, 2016, ten patients with markedly asymmetric parkinsonism that was poorly controlled pharmacologically were enrolled for focused ultrasound unilateral subthalamotomy. By 6 months follow-up, 38 incidents of adverse events had been recorded, none of which were serious or severe. Seven adverse events were present at 6 months. Three of these adverse events were directly related to subthalamotomy: off-medication dyskinesia in the treated arm (one patient, almost resolved by 6 months); on-medication dyskinesia in the treated arm (one patient, resolved after levodopa dose reduction); and subjective speech disturbance (one patient). Four of the adverse events present at 6 months were related to medical management (anxiety and fatigue [one patient each] and weight gain [two patients]). The most frequent adverse events were transient gait ataxia (related to subthalamotomy, six patients), transient pin-site head pain (related to the head fra |
| doi_str_mv | 10.1016/S1474-4422(17)30403-9 |
| format | Article |
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This prospective, open-label pilot study was done at CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur in Madrid, Spain. Eligible participants had Parkinson's disease with markedly asymmetric parkinsonism. Patients with severe dyskinesia, history of stereotactic surgery or brain haemorrhage, a diagnosis of an unstable cardiac or psychiatric disease, or a skull density ratio of 0·3 or less were excluded. Enrolled patients underwent focused ultrasound unilateral subthalamotomy. The subthalamic nucleus was targeted by means of brain images acquired with a 3-Tesla MRI apparatus. Several sonications above the definitive ablation temperature of 55°C were delivered and adjusted according to clinical response. The primary outcomes were safety and a change in the motor status of the treated hemibody as assessed with part III of the Movement Disorders Society–Unified Parkinson's Disease Rating Scale (MDS–UPDRS III) in both off-medication and on-medication states at 6 months. Adverse events were monitored up to 48 h after treatment and at scheduled clinic visits at 1, 3, and 6 months after treatment. The study is registered with ClinicalTrials.gov, number NCT02912871.
Between April 26 and June 14, 2016, ten patients with markedly asymmetric parkinsonism that was poorly controlled pharmacologically were enrolled for focused ultrasound unilateral subthalamotomy. By 6 months follow-up, 38 incidents of adverse events had been recorded, none of which were serious or severe. Seven adverse events were present at 6 months. Three of these adverse events were directly related to subthalamotomy: off-medication dyskinesia in the treated arm (one patient, almost resolved by 6 months); on-medication dyskinesia in the treated arm (one patient, resolved after levodopa dose reduction); and subjective speech disturbance (one patient). Four of the adverse events present at 6 months were related to medical management (anxiety and fatigue [one patient each] and weight gain [two patients]). The most frequent adverse events were transient gait ataxia (related to subthalamotomy, six patients), transient pin-site head pain (related to the head frame, six patients), and transient high blood pressure (during the procedure, five patients). Transient facial asymmetry (one patient) and moderate impulsivity (two patients) were also recorded. The mean MDS–UPDRS III score in the treated hemibody improved by 53% from baseline to 6 months in the off-medication state (16·6 [SD 2·9] vs 7·5 [3·9]) and by 47% in the on-medication state (11·9 [3·1] vs 5·8 [3·5]).
MRI-guided focused ultrasound unilateral subthalamotomy was well tolerated and seemed to improve motor features of Parkinson's disease in patients with noticeably asymmetric parkinsonism. Large randomised controlled trials are necessary to corroborate these preliminary findings and to assess the potential of such an approach to treat Parkinson's disease.
Fundación de investigación HM Hospitales and Insightec.</description><identifier>ISSN: 1474-4422</identifier><identifier>EISSN: 1474-4465</identifier><identifier>DOI: 10.1016/S1474-4422(17)30403-9</identifier><identifier>PMID: 29203153</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Ablation ; Adult ; Aged ; Ataxia ; Basal ganglia ; Blood pressure ; Brain research ; Central nervous system diseases ; Clinical trials ; Coronary artery disease ; Deep brain stimulation ; Drug withdrawal ; Drugs ; Dyskinesia ; Female ; Gait ; Heart diseases ; Hemorrhage ; Humans ; Hypertension ; Impulsive behavior ; Levodopa ; Magnetic Resonance Imaging ; Male ; Mental disorders ; Middle Aged ; Movement disorders ; Neurodegenerative diseases ; Neuronavigation - methods ; Neurosurgery ; NMR ; Nuclear magnetic resonance ; Outcome Assessment (Health Care) ; Parkinson Disease - diagnosis ; Parkinson Disease - surgery ; Parkinson's disease ; Patients ; Pilot Projects ; Postoperative Complications - physiopathology ; Postoperative Complications - psychology ; Psychiatry ; Skull ; Studies ; Subthalamic nucleus ; Subthalamic Nucleus - surgery ; Surgery ; Tremor (Muscular contraction) ; Ultrasonic imaging ; Ultrasonic Surgical Procedures - adverse effects ; Ultrasonic Surgical Procedures - methods ; Ultrasound</subject><ispartof>Lancet neurology, 2018-01, Vol.17 (1), p.54-63</ispartof><rights>2018 Elsevier Ltd</rights><rights>Copyright © 2018 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jan 1, 2018</rights><rights>2018. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c473t-28e73747ab60bbac1ea9f3c10ee725098be6b6d5e09888be7e1f9cc5a6bb9b683</citedby><cites>FETCH-LOGICAL-c473t-28e73747ab60bbac1ea9f3c10ee725098be6b6d5e09888be7e1f9cc5a6bb9b683</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/1983447754?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,776,780,3536,27903,27904,45974,64362,64364,64366,72216</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29203153$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Martínez-Fernández, Raul</creatorcontrib><creatorcontrib>Rodríguez-Rojas, Rafael</creatorcontrib><creatorcontrib>del Álamo, Marta</creatorcontrib><creatorcontrib>Hernández-Fernández, Frida</creatorcontrib><creatorcontrib>Pineda-Pardo, Jose A</creatorcontrib><creatorcontrib>Dileone, Michele</creatorcontrib><creatorcontrib>Alonso-Frech, Fernando</creatorcontrib><creatorcontrib>Foffani, Guglielmo</creatorcontrib><creatorcontrib>Obeso, Ignacio</creatorcontrib><creatorcontrib>Gasca-Salas, Carmen</creatorcontrib><creatorcontrib>de Luis-Pastor, Esther</creatorcontrib><creatorcontrib>Vela, Lydia</creatorcontrib><creatorcontrib>Obeso, José A</creatorcontrib><title>Focused ultrasound subthalamotomy in patients with asymmetric Parkinson's disease: a pilot study</title><title>Lancet neurology</title><addtitle>Lancet Neurol</addtitle><description>Ablative neurosurgery has been used to treat Parkinson's disease for many decades. MRI-guided focused ultrasound allows focal lesions to be made in deep brain structures without skull incision. We investigated the safety and preliminary efficacy of unilateral subthalamotomy by focused ultrasound in Parkinson's disease.
This prospective, open-label pilot study was done at CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur in Madrid, Spain. Eligible participants had Parkinson's disease with markedly asymmetric parkinsonism. Patients with severe dyskinesia, history of stereotactic surgery or brain haemorrhage, a diagnosis of an unstable cardiac or psychiatric disease, or a skull density ratio of 0·3 or less were excluded. Enrolled patients underwent focused ultrasound unilateral subthalamotomy. The subthalamic nucleus was targeted by means of brain images acquired with a 3-Tesla MRI apparatus. Several sonications above the definitive ablation temperature of 55°C were delivered and adjusted according to clinical response. The primary outcomes were safety and a change in the motor status of the treated hemibody as assessed with part III of the Movement Disorders Society–Unified Parkinson's Disease Rating Scale (MDS–UPDRS III) in both off-medication and on-medication states at 6 months. Adverse events were monitored up to 48 h after treatment and at scheduled clinic visits at 1, 3, and 6 months after treatment. The study is registered with ClinicalTrials.gov, number NCT02912871.
Between April 26 and June 14, 2016, ten patients with markedly asymmetric parkinsonism that was poorly controlled pharmacologically were enrolled for focused ultrasound unilateral subthalamotomy. By 6 months follow-up, 38 incidents of adverse events had been recorded, none of which were serious or severe. Seven adverse events were present at 6 months. Three of these adverse events were directly related to subthalamotomy: off-medication dyskinesia in the treated arm (one patient, almost resolved by 6 months); on-medication dyskinesia in the treated arm (one patient, resolved after levodopa dose reduction); and subjective speech disturbance (one patient). Four of the adverse events present at 6 months were related to medical management (anxiety and fatigue [one patient each] and weight gain [two patients]). The most frequent adverse events were transient gait ataxia (related to subthalamotomy, six patients), transient pin-site head pain (related to the head frame, six patients), and transient high blood pressure (during the procedure, five patients). Transient facial asymmetry (one patient) and moderate impulsivity (two patients) were also recorded. The mean MDS–UPDRS III score in the treated hemibody improved by 53% from baseline to 6 months in the off-medication state (16·6 [SD 2·9] vs 7·5 [3·9]) and by 47% in the on-medication state (11·9 [3·1] vs 5·8 [3·5]).
MRI-guided focused ultrasound unilateral subthalamotomy was well tolerated and seemed to improve motor features of Parkinson's disease in patients with noticeably asymmetric parkinsonism. Large randomised controlled trials are necessary to corroborate these preliminary findings and to assess the potential of such an approach to treat Parkinson's disease.
Fundación de investigación HM Hospitales and Insightec.</description><subject>Ablation</subject><subject>Adult</subject><subject>Aged</subject><subject>Ataxia</subject><subject>Basal ganglia</subject><subject>Blood pressure</subject><subject>Brain research</subject><subject>Central nervous system diseases</subject><subject>Clinical trials</subject><subject>Coronary artery disease</subject><subject>Deep brain stimulation</subject><subject>Drug withdrawal</subject><subject>Drugs</subject><subject>Dyskinesia</subject><subject>Female</subject><subject>Gait</subject><subject>Heart diseases</subject><subject>Hemorrhage</subject><subject>Humans</subject><subject>Hypertension</subject><subject>Impulsive behavior</subject><subject>Levodopa</subject><subject>Magnetic Resonance Imaging</subject><subject>Male</subject><subject>Mental disorders</subject><subject>Middle Aged</subject><subject>Movement disorders</subject><subject>Neurodegenerative diseases</subject><subject>Neuronavigation - methods</subject><subject>Neurosurgery</subject><subject>NMR</subject><subject>Nuclear magnetic resonance</subject><subject>Outcome Assessment (Health Care)</subject><subject>Parkinson Disease - diagnosis</subject><subject>Parkinson Disease - surgery</subject><subject>Parkinson's disease</subject><subject>Patients</subject><subject>Pilot Projects</subject><subject>Postoperative Complications - physiopathology</subject><subject>Postoperative Complications - psychology</subject><subject>Psychiatry</subject><subject>Skull</subject><subject>Studies</subject><subject>Subthalamic nucleus</subject><subject>Subthalamic Nucleus - surgery</subject><subject>Surgery</subject><subject>Tremor (Muscular contraction)</subject><subject>Ultrasonic imaging</subject><subject>Ultrasonic Surgical Procedures - adverse effects</subject><subject>Ultrasonic Surgical Procedures - methods</subject><subject>Ultrasound</subject><issn>1474-4422</issn><issn>1474-4465</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqFkU1v1DAQQC0Eou3CTwBZ4kA5pPgrdsIFoYpCpUogAWdjO7OqSxIvHptq_33T7tIDB3qaGevNjO1HyAvOTjjj-u03roxqlBLimJs3kikmm_4ROdwf6_bxfS7EATlCvGJMcNXxp-RA9IJJ3spD8vMshYow0DqW7DDVeaBYfbl0o5tSSdOWxpluXIkwF6TXsVxSh9tpgpJjoF9d_hVnTPNrpENEcAjvqKObOKZCsdRh-4w8WbsR4fk-rsiPs4_fTz83F18-nZ9-uGiCMrI0ogMjjTLOa-a9Cxxcv5aBMwAjWtZ3HrTXQwtL2i2FAb7uQ2id9r73upMrcrybu8npdwUsdooYYBzdDKmi5b2RTEizPHxFXv2DXqWa5-V2ViitpNJa8v9RvO-kUsa0aqHaHRVyQsywtpscJ5e3ljN7K8reibK3Fiw39k6U7Ze-l_vp1U8w3Hf9NbMA73cALJ_2J0K2GBYHAYaYIRQ7pPjAihv0X6LN</recordid><startdate>201801</startdate><enddate>201801</enddate><creator>Martínez-Fernández, Raul</creator><creator>Rodríguez-Rojas, Rafael</creator><creator>del Álamo, Marta</creator><creator>Hernández-Fernández, Frida</creator><creator>Pineda-Pardo, Jose A</creator><creator>Dileone, Michele</creator><creator>Alonso-Frech, Fernando</creator><creator>Foffani, Guglielmo</creator><creator>Obeso, Ignacio</creator><creator>Gasca-Salas, Carmen</creator><creator>de Luis-Pastor, Esther</creator><creator>Vela, Lydia</creator><creator>Obeso, José A</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><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>201801</creationdate><title>Focused ultrasound subthalamotomy in patients with asymmetric Parkinson's disease: a pilot study</title><author>Martínez-Fernández, Raul ; Rodríguez-Rojas, Rafael ; del Álamo, Marta ; Hernández-Fernández, Frida ; Pineda-Pardo, Jose A ; Dileone, Michele ; Alonso-Frech, Fernando ; Foffani, Guglielmo ; Obeso, Ignacio ; Gasca-Salas, Carmen ; de Luis-Pastor, Esther ; Vela, Lydia ; Obeso, José A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c473t-28e73747ab60bbac1ea9f3c10ee725098be6b6d5e09888be7e1f9cc5a6bb9b683</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Ablation</topic><topic>Adult</topic><topic>Aged</topic><topic>Ataxia</topic><topic>Basal ganglia</topic><topic>Blood pressure</topic><topic>Brain research</topic><topic>Central nervous system diseases</topic><topic>Clinical trials</topic><topic>Coronary artery disease</topic><topic>Deep brain stimulation</topic><topic>Drug withdrawal</topic><topic>Drugs</topic><topic>Dyskinesia</topic><topic>Female</topic><topic>Gait</topic><topic>Heart diseases</topic><topic>Hemorrhage</topic><topic>Humans</topic><topic>Hypertension</topic><topic>Impulsive behavior</topic><topic>Levodopa</topic><topic>Magnetic Resonance Imaging</topic><topic>Male</topic><topic>Mental disorders</topic><topic>Middle Aged</topic><topic>Movement disorders</topic><topic>Neurodegenerative diseases</topic><topic>Neuronavigation - methods</topic><topic>Neurosurgery</topic><topic>NMR</topic><topic>Nuclear magnetic resonance</topic><topic>Outcome Assessment (Health Care)</topic><topic>Parkinson Disease - diagnosis</topic><topic>Parkinson Disease - surgery</topic><topic>Parkinson's disease</topic><topic>Patients</topic><topic>Pilot Projects</topic><topic>Postoperative Complications - physiopathology</topic><topic>Postoperative Complications - psychology</topic><topic>Psychiatry</topic><topic>Skull</topic><topic>Studies</topic><topic>Subthalamic nucleus</topic><topic>Subthalamic Nucleus - surgery</topic><topic>Surgery</topic><topic>Tremor (Muscular contraction)</topic><topic>Ultrasonic imaging</topic><topic>Ultrasonic Surgical Procedures - adverse effects</topic><topic>Ultrasonic Surgical Procedures - methods</topic><topic>Ultrasound</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Martínez-Fernández, Raul</creatorcontrib><creatorcontrib>Rodríguez-Rojas, Rafael</creatorcontrib><creatorcontrib>del Álamo, Marta</creatorcontrib><creatorcontrib>Hernández-Fernández, Frida</creatorcontrib><creatorcontrib>Pineda-Pardo, Jose A</creatorcontrib><creatorcontrib>Dileone, Michele</creatorcontrib><creatorcontrib>Alonso-Frech, Fernando</creatorcontrib><creatorcontrib>Foffani, Guglielmo</creatorcontrib><creatorcontrib>Obeso, Ignacio</creatorcontrib><creatorcontrib>Gasca-Salas, Carmen</creatorcontrib><creatorcontrib>de Luis-Pastor, Esther</creatorcontrib><creatorcontrib>Vela, Lydia</creatorcontrib><creatorcontrib>Obeso, José A</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><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>ProQuest Psychology</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>Martínez-Fernández, Raul</au><au>Rodríguez-Rojas, Rafael</au><au>del Álamo, Marta</au><au>Hernández-Fernández, Frida</au><au>Pineda-Pardo, Jose A</au><au>Dileone, Michele</au><au>Alonso-Frech, Fernando</au><au>Foffani, Guglielmo</au><au>Obeso, Ignacio</au><au>Gasca-Salas, Carmen</au><au>de Luis-Pastor, Esther</au><au>Vela, Lydia</au><au>Obeso, José A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Focused ultrasound subthalamotomy in patients with asymmetric Parkinson's disease: a pilot study</atitle><jtitle>Lancet neurology</jtitle><addtitle>Lancet Neurol</addtitle><date>2018-01</date><risdate>2018</risdate><volume>17</volume><issue>1</issue><spage>54</spage><epage>63</epage><pages>54-63</pages><issn>1474-4422</issn><eissn>1474-4465</eissn><abstract>Ablative neurosurgery has been used to treat Parkinson's disease for many decades. MRI-guided focused ultrasound allows focal lesions to be made in deep brain structures without skull incision. We investigated the safety and preliminary efficacy of unilateral subthalamotomy by focused ultrasound in Parkinson's disease.
This prospective, open-label pilot study was done at CINAC (Centro Integral de Neurociencias), University Hospital HM Puerta del Sur in Madrid, Spain. Eligible participants had Parkinson's disease with markedly asymmetric parkinsonism. Patients with severe dyskinesia, history of stereotactic surgery or brain haemorrhage, a diagnosis of an unstable cardiac or psychiatric disease, or a skull density ratio of 0·3 or less were excluded. Enrolled patients underwent focused ultrasound unilateral subthalamotomy. The subthalamic nucleus was targeted by means of brain images acquired with a 3-Tesla MRI apparatus. Several sonications above the definitive ablation temperature of 55°C were delivered and adjusted according to clinical response. The primary outcomes were safety and a change in the motor status of the treated hemibody as assessed with part III of the Movement Disorders Society–Unified Parkinson's Disease Rating Scale (MDS–UPDRS III) in both off-medication and on-medication states at 6 months. Adverse events were monitored up to 48 h after treatment and at scheduled clinic visits at 1, 3, and 6 months after treatment. The study is registered with ClinicalTrials.gov, number NCT02912871.
Between April 26 and June 14, 2016, ten patients with markedly asymmetric parkinsonism that was poorly controlled pharmacologically were enrolled for focused ultrasound unilateral subthalamotomy. By 6 months follow-up, 38 incidents of adverse events had been recorded, none of which were serious or severe. Seven adverse events were present at 6 months. Three of these adverse events were directly related to subthalamotomy: off-medication dyskinesia in the treated arm (one patient, almost resolved by 6 months); on-medication dyskinesia in the treated arm (one patient, resolved after levodopa dose reduction); and subjective speech disturbance (one patient). Four of the adverse events present at 6 months were related to medical management (anxiety and fatigue [one patient each] and weight gain [two patients]). The most frequent adverse events were transient gait ataxia (related to subthalamotomy, six patients), transient pin-site head pain (related to the head frame, six patients), and transient high blood pressure (during the procedure, five patients). Transient facial asymmetry (one patient) and moderate impulsivity (two patients) were also recorded. The mean MDS–UPDRS III score in the treated hemibody improved by 53% from baseline to 6 months in the off-medication state (16·6 [SD 2·9] vs 7·5 [3·9]) and by 47% in the on-medication state (11·9 [3·1] vs 5·8 [3·5]).
MRI-guided focused ultrasound unilateral subthalamotomy was well tolerated and seemed to improve motor features of Parkinson's disease in patients with noticeably asymmetric parkinsonism. Large randomised controlled trials are necessary to corroborate these preliminary findings and to assess the potential of such an approach to treat Parkinson's disease.
Fundación de investigación HM Hospitales and Insightec.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>29203153</pmid><doi>10.1016/S1474-4422(17)30403-9</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1474-4422 |
| ispartof | Lancet neurology, 2018-01, Vol.17 (1), p.54-63 |
| issn | 1474-4422 1474-4465 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1973023720 |
| source | MEDLINE; Elsevier ScienceDirect Journals; ProQuest Central UK/Ireland |
| subjects | Ablation Adult Aged Ataxia Basal ganglia Blood pressure Brain research Central nervous system diseases Clinical trials Coronary artery disease Deep brain stimulation Drug withdrawal Drugs Dyskinesia Female Gait Heart diseases Hemorrhage Humans Hypertension Impulsive behavior Levodopa Magnetic Resonance Imaging Male Mental disorders Middle Aged Movement disorders Neurodegenerative diseases Neuronavigation - methods Neurosurgery NMR Nuclear magnetic resonance Outcome Assessment (Health Care) Parkinson Disease - diagnosis Parkinson Disease - surgery Parkinson's disease Patients Pilot Projects Postoperative Complications - physiopathology Postoperative Complications - psychology Psychiatry Skull Studies Subthalamic nucleus Subthalamic Nucleus - surgery Surgery Tremor (Muscular contraction) Ultrasonic imaging Ultrasonic Surgical Procedures - adverse effects Ultrasonic Surgical Procedures - methods Ultrasound |
| title | Focused ultrasound subthalamotomy in patients with asymmetric Parkinson's disease: a pilot study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-23T07%3A51%3A17IST&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=Focused%20ultrasound%20subthalamotomy%20in%20patients%20with%20asymmetric%20Parkinson's%20disease:%20a%20pilot%20study&rft.jtitle=Lancet%20neurology&rft.au=Mart%C3%ADnez-Fern%C3%A1ndez,%20Raul&rft.date=2018-01&rft.volume=17&rft.issue=1&rft.spage=54&rft.epage=63&rft.pages=54-63&rft.issn=1474-4422&rft.eissn=1474-4465&rft_id=info:doi/10.1016/S1474-4422(17)30403-9&rft_dat=%3Cproquest_cross%3E1973023720%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=1983447754&rft_id=info:pmid/29203153&rft_els_id=S1474442217304039&rfr_iscdi=true |