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A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia

Primary Purpose

Dystonia

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Deep Brain Stimulation (DBS) of Gpi
Deep Brain Stimulation (DBS) of STN
Sponsored by
Beijing Pins Medical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystonia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is aged 18 to 75 years old, male or female.
  2. Diagnosed with cervical dystonia by a movement disorders neurologist.
  3. Has cervical dystonia alone, not generalized or multifocal.
  4. Has had adequate trials of medical therapy.

Exclusion Criteria:

  1. Cognitive impairment.
  2. Abnormalities on pre-operative magnetic resonance imaging (MRI).
  3. Medical conditions precluding general anaesthetic or surgery.
  4. Unstable psychiatric disease.
  5. Previous brain lesions to treat cervical dystonia.
  6. Attended some other trials within three month.

Sites / Locations

  • Peking union medical college hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Deep Brain Stimulation

Placebo

Arm Description

Stimulation is on

Stimulation is off

Outcomes

Primary Outcome Measures

Burke-Fahn-Marsden Scale (BFM)

Secondary Outcome Measures

Quality of life (SF-36)
Psychiatric assessment (HADS-D and PANSS)

Full Information

First Posted
September 27, 2014
Last Updated
February 27, 2023
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02263417
Brief Title
A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia
Official Title
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN and Gpi of 40 patients with dystonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Deep Brain Stimulation
Arm Type
Active Comparator
Arm Description
Stimulation is on
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Stimulation is off
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation (DBS) of Gpi
Other Intervention Name(s)
Rechargeable Neurostimulator
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation (DBS) of STN
Other Intervention Name(s)
Rechargeable Neurostimulator
Primary Outcome Measure Information:
Title
Burke-Fahn-Marsden Scale (BFM)
Time Frame
Change from baseline in BMF at 1, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Quality of life (SF-36)
Time Frame
Change from baseline in SF-36 at 1, 3 months and 6 months
Title
Psychiatric assessment (HADS-D and PANSS)
Time Frame
Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Luming, PhD
Organizational Affiliation
Tsinghua University
Official's Role
Study Chair
Facility Information:
Facility Name
Peking union medical college hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China

12. IPD Sharing Statement

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A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia

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