Evidence map›Paper›PMID 36567243›Full record

ArticleNeuromodulation : journal of the International Neuromodulation Society2023

Eleven-Year Outcomes of Deep Brain Stimulation in Early-Stage Parkinson Disease.

Mallory L Hacker, Jacqueline C Meystedt, Maxim Turchan, Kevin R Cannard, Kelly Harper, Run Fan, Fei Ye, Thomas L Davis, Peter E Konrad, David Charles

Registry-linked trialOpen access · greenAbstract read
In one paragraph

Article in Neuromodulation : journal of the International Neuromodulation Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00282152 (Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00282152 nacompletednot on this map

Safety and Tolerability of Neurostimulation in Early Stage Parkinson's Disease

TypeinterventionalSponsorVanderbilt University Medical CenterRan2006 to 2015Enrolled37ConditionsParkinson's DiseaseArmsB-STN DBS, Optimal drug therapy
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Advanced Therapeutics in Parkinson's Disease: What's New?Current neurology and neuroscience reports · 2026
    Review
  6. Article
  7. Article
  8. Advanced therapies in Parkinson's disease: an individualized approach to their indication.Journal of neural transmission (Vienna, Austria : 1996) · 2024
    Review
  9. Deep brain stimulation for Tourette's syndrome.The Cochrane database of systematic reviews · 2024
    Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Mallory L HackerDepartment of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA. Electronic address: Mallory.Hacker@vumc.org.
Jacqueline C MeystedtDepartment of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.
Maxim TurchanDepartment of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.
Kevin R CannardDepartment of Neurology, Walter Reed National Military Center, Bethesda, MD, USA.
Kelly HarperDepartment of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.
Run FanDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Fei YeDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Thomas L DavisDepartment of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.
Peter E KonradDepartment of Neurosurgery, West Virginia University, Morgantown, WV, USA.
David CharlesDepartment of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.
Vanderbilt University Medical Center · USWalter Reed National Military Medical Center · USWest Virginia University · US

Funding

Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
Feasibility of Objective Measures and Outpatient Washout in Disease-Modifying Trials for Parkinson's DiseaseK01AG066971 · NIA · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HACKER, MALLORY L. · 2021 to 2025
$596k
Investigating Long-Term Clinical Outcomes and Metabolic Network Activity Following Subthalamic Nucleus Deep Brain Stimulation in Early Stage Parkinson's DiseaseR21NS107877 · NINDS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HACKER, MALLORY L. · 2018 to 2019
$425k
NCATS NIH HHS UL1 TR002243NIA NIH HHS K01 AG066971NINDS NIH HHS R21 NS107877
6 · The paper itself

Abstract

objectiveThe 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. MATERIALS AND

methodsAttempts 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.

resultsTwelve 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; p

conclusionsEleven 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). CLINICAL

trial registrationThe Clinicaltrials.gov registration number for the study is NCT00282152.

Indexed as

Deep Brain StimulationParkinson DiseaseSubthalamic NucleusAgedFollow-Up StudiesHumansLevodopaTreatment OutcomeLevodopaDeep brain stimulationdyskinesialongitudinal studiesmovement disordersParkinson disease

Identifiers

PMID36567243
PMCPMC10198566
OpenAlexW4312118218

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.