A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Dystonia
1 other identifier
interventional
70
1 country
1
Brief Summary
The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2014
CompletedFirst Posted
Study publicly available on registry
October 13, 2014
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedMarch 1, 2023
February 1, 2023
4.4 years
September 27, 2014
February 27, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Burke-Fahn-Marsden Scale (BFM)
Change from baseline in BMF at 1, 3 months and 6 months
Secondary Outcomes (2)
Quality of life (SF-36)
Change from baseline in SF-36 at 1, 3 months and 6 months
Psychiatric assessment (HADS-D and PANSS)
Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months
Study Arms (2)
Deep Brain Stimulation
ACTIVE COMPARATORStimulation is on
Placebo
SHAM COMPARATORStimulation is off
Interventions
Eligibility Criteria
You may qualify if:
- Subject is aged 18 to 75 years old, male or female.
- Diagnosed with cervical dystonia by a movement disorders neurologist.
- Has cervical dystonia alone, not generalized or multifocal.
- Has had adequate trials of medical therapy.
You may not qualify if:
- Cognitive impairment.
- Abnormalities on pre-operative magnetic resonance imaging (MRI).
- Medical conditions precluding general anaesthetic or surgery.
- Unstable psychiatric disease.
- Previous brain lesions to treat cervical dystonia.
- Attended some other trials within three month.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking union medical college hospital
Beijing, Beijing Municipality, 100032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Li Luming, PhD
Tsinghua University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2014
First Posted
October 13, 2014
Study Start
July 1, 2015
Primary Completion
December 1, 2019
Study Completion
June 1, 2020
Last Updated
March 1, 2023
Record last verified: 2023-02