Eleven-Year Outcomes of Deep Brain Stimulation in Early-Stage Parkinson Disease
The deep brain stimulation (DBS) in early-stage Parkinson's disease (PD) pilot clinical trial randomized 30 patients (Hoehn & Yahr II off; medication duration 0.5–4 years; without dyskinesia/motor fluctuations) to optimal drug therapy (ODT) (early ODT) or bilateral subthalamic nucleus (STN)...
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| Veröffentlicht in: | Neuromodulation (Malden, Mass.) Mass.), 2023-02, Vol.26 (2), p.451-458 |
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| creator | Hacker, Mallory L. Meystedt, Jacqueline C. Turchan, Maxim Cannard, Kevin R. Harper, Kelly Fan, Run Ye, Fei Davis, Thomas L. Konrad, Peter E. Charles, David |
| description | The deep brain stimulation (DBS) in early-stage Parkinson's disease (PD) pilot clinical trial randomized 30 patients (Hoehn & Yahr II off; medication duration 0.5–4 years; without dyskinesia/motor fluctuations) to optimal drug therapy (ODT) (early ODT) or bilateral subthalamic nucleus (STN) DBS plus ODT (early DBS+ODT). This study aims to report the 11-year outcomes of patients who completed the DBS in early-stage PD pilot clinical trial.
Attempts were made to contact all 29 subjects who completed the two-year trial to participate in an 11-year follow-up study. Mixed-effects models compared overall trend in outcomes for randomization groups (fixed-effects: assigned treatment, year, their interaction; random-effect: subject) to account for repeated measures.
Twelve subjects participated in this 11-year follow-up study (n = 8 early ODT, n = 4 early DBS+ODT). Participating subjects were 70.0 ± 4.8 years old with a PD medication duration of 13.7 ± 1.7 years (early DBS duration 11.5 ± 1.3 years, n = 4). Three early ODT subjects received STN-DBS as standard of care (DBS duration 6.5 ± 2.0 years). Early ODT subjects had worse motor complications (Unified Parkinson’s Disease Rating Scale [UPDRS]–IV) than early DBS+ODT subjects over the 11-year follow-up period (between-group difference = 3.5 points; pinteraction = 0.03). Early DBS+ODT was well-tolerated after 11 years and showed comparable outcomes to early ODT for other UPDRS domains, Parkinson Disease Questionnaire–39 (PDQ-39), and levodopa equivalent daily dose (LEDD).
Eleven years after randomization, early DBS+ODT subjects had fewer motor complications than early ODT subjects. These results should be interpreted with caution because only 40% of pilot trial subjects participated in this 11-year follow-up study. The Food and Drug Administration has approved the conduct of a pivotal clinical trial evaluating DBS in early-stage PD (IDEG050016).
The Clinicaltrials.gov registration number for the study is NCT00282152. |
| doi_str_mv | 10.1016/j.neurom.2022.10.051 |
| format | Article |
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Attempts were made to contact all 29 subjects who completed the two-year trial to participate in an 11-year follow-up study. Mixed-effects models compared overall trend in outcomes for randomization groups (fixed-effects: assigned treatment, year, their interaction; random-effect: subject) to account for repeated measures.
Twelve subjects participated in this 11-year follow-up study (n = 8 early ODT, n = 4 early DBS+ODT). Participating subjects were 70.0 ± 4.8 years old with a PD medication duration of 13.7 ± 1.7 years (early DBS duration 11.5 ± 1.3 years, n = 4). Three early ODT subjects received STN-DBS as standard of care (DBS duration 6.5 ± 2.0 years). Early ODT subjects had worse motor complications (Unified Parkinson’s Disease Rating Scale [UPDRS]–IV) than early DBS+ODT subjects over the 11-year follow-up period (between-group difference = 3.5 points; pinteraction = 0.03). Early DBS+ODT was well-tolerated after 11 years and showed comparable outcomes to early ODT for other UPDRS domains, Parkinson Disease Questionnaire–39 (PDQ-39), and levodopa equivalent daily dose (LEDD).
Eleven years after randomization, early DBS+ODT subjects had fewer motor complications than early ODT subjects. These results should be interpreted with caution because only 40% of pilot trial subjects participated in this 11-year follow-up study. The Food and Drug Administration has approved the conduct of a pivotal clinical trial evaluating DBS in early-stage PD (IDEG050016).
The Clinicaltrials.gov registration number for the study is NCT00282152.</description><identifier>ISSN: 1094-7159</identifier><identifier>ISSN: 1525-1403</identifier><identifier>EISSN: 1525-1403</identifier><identifier>DOI: 10.1016/j.neurom.2022.10.051</identifier><identifier>PMID: 36567243</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Deep brain stimulation ; Deep Brain Stimulation - methods ; dyskinesia ; Follow-Up Studies ; Humans ; Levodopa - therapeutic use ; longitudinal studies ; movement disorders ; Parkinson disease ; Parkinson Disease - drug therapy ; Subthalamic Nucleus - physiology ; Treatment Outcome</subject><ispartof>Neuromodulation (Malden, Mass.), 2023-02, Vol.26 (2), p.451-458</ispartof><rights>2022 International Neuromodulation Society</rights><rights>Copyright © 2022 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c408t-79b78902d04ec16ddca457345f5e80a0a1473ab7272726524f644c182f4f21b23</citedby><cites>FETCH-LOGICAL-c408t-79b78902d04ec16ddca457345f5e80a0a1473ab7272726524f644c182f4f21b23</cites><orcidid>0000-0003-1498-4509</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36567243$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hacker, Mallory L.</creatorcontrib><creatorcontrib>Meystedt, Jacqueline C.</creatorcontrib><creatorcontrib>Turchan, Maxim</creatorcontrib><creatorcontrib>Cannard, Kevin R.</creatorcontrib><creatorcontrib>Harper, Kelly</creatorcontrib><creatorcontrib>Fan, Run</creatorcontrib><creatorcontrib>Ye, Fei</creatorcontrib><creatorcontrib>Davis, Thomas L.</creatorcontrib><creatorcontrib>Konrad, Peter E.</creatorcontrib><creatorcontrib>Charles, David</creatorcontrib><title>Eleven-Year Outcomes of Deep Brain Stimulation in Early-Stage Parkinson Disease</title><title>Neuromodulation (Malden, Mass.)</title><addtitle>Neuromodulation</addtitle><description>The deep brain stimulation (DBS) in early-stage Parkinson's disease (PD) pilot clinical trial randomized 30 patients (Hoehn & Yahr II off; medication duration 0.5–4 years; without dyskinesia/motor fluctuations) to optimal drug therapy (ODT) (early ODT) or bilateral subthalamic nucleus (STN) DBS plus ODT (early DBS+ODT). This study aims to report the 11-year outcomes of patients who completed the DBS in early-stage PD pilot clinical trial.
Attempts were made to contact all 29 subjects who completed the two-year trial to participate in an 11-year follow-up study. Mixed-effects models compared overall trend in outcomes for randomization groups (fixed-effects: assigned treatment, year, their interaction; random-effect: subject) to account for repeated measures.
Twelve subjects participated in this 11-year follow-up study (n = 8 early ODT, n = 4 early DBS+ODT). Participating subjects were 70.0 ± 4.8 years old with a PD medication duration of 13.7 ± 1.7 years (early DBS duration 11.5 ± 1.3 years, n = 4). Three early ODT subjects received STN-DBS as standard of care (DBS duration 6.5 ± 2.0 years). Early ODT subjects had worse motor complications (Unified Parkinson’s Disease Rating Scale [UPDRS]–IV) than early DBS+ODT subjects over the 11-year follow-up period (between-group difference = 3.5 points; pinteraction = 0.03). Early DBS+ODT was well-tolerated after 11 years and showed comparable outcomes to early ODT for other UPDRS domains, Parkinson Disease Questionnaire–39 (PDQ-39), and levodopa equivalent daily dose (LEDD).
Eleven years after randomization, early DBS+ODT subjects had fewer motor complications than early ODT subjects. These results should be interpreted with caution because only 40% of pilot trial subjects participated in this 11-year follow-up study. The Food and Drug Administration has approved the conduct of a pivotal clinical trial evaluating DBS in early-stage PD (IDEG050016).
The Clinicaltrials.gov registration number for the study is NCT00282152.</description><subject>Aged</subject><subject>Deep brain stimulation</subject><subject>Deep Brain Stimulation - methods</subject><subject>dyskinesia</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Levodopa - therapeutic use</subject><subject>longitudinal studies</subject><subject>movement disorders</subject><subject>Parkinson disease</subject><subject>Parkinson Disease - drug therapy</subject><subject>Subthalamic Nucleus - physiology</subject><subject>Treatment Outcome</subject><issn>1094-7159</issn><issn>1525-1403</issn><issn>1525-1403</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kMlOwzAQhi0EoqXwBgjlyCXBduw4uSBBWxapUpEKB06W40yQS5ZiJ5X69jgKcERzmO2fGc2H0CXBEcEkudlGDfS2rSOKKfWlCHNyhKaEUx4ShuNjH-OMhYLwbILOnNtiTERGxSmaxAlPBGXxFK2XFeyhCd9B2WDdd7qtwQVtGSwAdsG9VaYJNp2p-0p1pm0Cny6VrQ7hplMfELwo-2ka5xsL40A5OEcnpaocXPz4GXp7WL7On8LV-vF5frcKNcNpF4osF2mGaYEZaJIUhVaMi5jxkkOKFVaEiVjlgg6WcMrKhDFNUlqykpKcxjN0Pe7d2farB9fJ2jgNVaUaaHsnqeBpzBkRsZeyUapt65yFUu6sqZU9SILlgFJu5YhSDiiHqkfpx65-LvR5DcXf0C87L7gdBeD_3Buw0mkDjYbCWNCdLFrz_4Vv00WFRA</recordid><startdate>202302</startdate><enddate>202302</enddate><creator>Hacker, Mallory L.</creator><creator>Meystedt, Jacqueline C.</creator><creator>Turchan, Maxim</creator><creator>Cannard, Kevin R.</creator><creator>Harper, Kelly</creator><creator>Fan, Run</creator><creator>Ye, Fei</creator><creator>Davis, Thomas L.</creator><creator>Konrad, Peter E.</creator><creator>Charles, David</creator><general>Elsevier Inc</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>7X8</scope><orcidid>https://orcid.org/0000-0003-1498-4509</orcidid></search><sort><creationdate>202302</creationdate><title>Eleven-Year Outcomes of Deep Brain Stimulation in Early-Stage Parkinson Disease</title><author>Hacker, Mallory L. ; Meystedt, Jacqueline C. ; Turchan, Maxim ; Cannard, Kevin R. ; Harper, Kelly ; Fan, Run ; Ye, Fei ; Davis, Thomas L. ; Konrad, Peter E. ; Charles, David</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c408t-79b78902d04ec16ddca457345f5e80a0a1473ab7272726524f644c182f4f21b23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Aged</topic><topic>Deep brain stimulation</topic><topic>Deep Brain Stimulation - methods</topic><topic>dyskinesia</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Levodopa - therapeutic use</topic><topic>longitudinal studies</topic><topic>movement disorders</topic><topic>Parkinson disease</topic><topic>Parkinson Disease - drug therapy</topic><topic>Subthalamic Nucleus - physiology</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hacker, Mallory L.</creatorcontrib><creatorcontrib>Meystedt, Jacqueline C.</creatorcontrib><creatorcontrib>Turchan, Maxim</creatorcontrib><creatorcontrib>Cannard, Kevin R.</creatorcontrib><creatorcontrib>Harper, Kelly</creatorcontrib><creatorcontrib>Fan, Run</creatorcontrib><creatorcontrib>Ye, Fei</creatorcontrib><creatorcontrib>Davis, Thomas L.</creatorcontrib><creatorcontrib>Konrad, Peter E.</creatorcontrib><creatorcontrib>Charles, David</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Neuromodulation (Malden, Mass.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hacker, Mallory L.</au><au>Meystedt, Jacqueline C.</au><au>Turchan, Maxim</au><au>Cannard, Kevin R.</au><au>Harper, Kelly</au><au>Fan, Run</au><au>Ye, Fei</au><au>Davis, Thomas L.</au><au>Konrad, Peter E.</au><au>Charles, David</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Eleven-Year Outcomes of Deep Brain Stimulation in Early-Stage Parkinson Disease</atitle><jtitle>Neuromodulation (Malden, Mass.)</jtitle><addtitle>Neuromodulation</addtitle><date>2023-02</date><risdate>2023</risdate><volume>26</volume><issue>2</issue><spage>451</spage><epage>458</epage><pages>451-458</pages><issn>1094-7159</issn><issn>1525-1403</issn><eissn>1525-1403</eissn><abstract>The deep brain stimulation (DBS) in early-stage Parkinson's disease (PD) pilot clinical trial randomized 30 patients (Hoehn & Yahr II off; medication duration 0.5–4 years; without dyskinesia/motor fluctuations) to optimal drug therapy (ODT) (early ODT) or bilateral subthalamic nucleus (STN) DBS plus ODT (early DBS+ODT). This study aims to report the 11-year outcomes of patients who completed the DBS in early-stage PD pilot clinical trial.
Attempts were made to contact all 29 subjects who completed the two-year trial to participate in an 11-year follow-up study. Mixed-effects models compared overall trend in outcomes for randomization groups (fixed-effects: assigned treatment, year, their interaction; random-effect: subject) to account for repeated measures.
Twelve subjects participated in this 11-year follow-up study (n = 8 early ODT, n = 4 early DBS+ODT). Participating subjects were 70.0 ± 4.8 years old with a PD medication duration of 13.7 ± 1.7 years (early DBS duration 11.5 ± 1.3 years, n = 4). Three early ODT subjects received STN-DBS as standard of care (DBS duration 6.5 ± 2.0 years). Early ODT subjects had worse motor complications (Unified Parkinson’s Disease Rating Scale [UPDRS]–IV) than early DBS+ODT subjects over the 11-year follow-up period (between-group difference = 3.5 points; pinteraction = 0.03). Early DBS+ODT was well-tolerated after 11 years and showed comparable outcomes to early ODT for other UPDRS domains, Parkinson Disease Questionnaire–39 (PDQ-39), and levodopa equivalent daily dose (LEDD).
Eleven years after randomization, early DBS+ODT subjects had fewer motor complications than early ODT subjects. These results should be interpreted with caution because only 40% of pilot trial subjects participated in this 11-year follow-up study. The Food and Drug Administration has approved the conduct of a pivotal clinical trial evaluating DBS in early-stage PD (IDEG050016).
The Clinicaltrials.gov registration number for the study is NCT00282152.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>36567243</pmid><doi>10.1016/j.neurom.2022.10.051</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0003-1498-4509</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Aged Deep brain stimulation Deep Brain Stimulation - methods dyskinesia Follow-Up Studies Humans Levodopa - therapeutic use longitudinal studies movement disorders Parkinson disease Parkinson Disease - drug therapy Subthalamic Nucleus - physiology Treatment Outcome |
| title | Eleven-Year Outcomes of Deep Brain Stimulation in Early-Stage Parkinson Disease |
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