A Randomized Controlled Trail Comparing Subthalamic and P... | NCT02263417

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

NCT02263417

Sponsor

Beijing Pins Medical Co., Ltd

Status

Completed

Last Update Posted

Mar 1, 2023Actual

Enrollment

70Actual

Phase

Phase 4

Conditions

Dystonia

Interventions

Deep Brain Stimulation (DBS) of Gpi
Deep Brain Stimulation (DBS) of STN

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Dec 2019Actual

Completion Date

Jun 2020Actual

First Submitted Date

Sep 27, 2014

First Submission Date that Met QC Criteria

Oct 8, 2014

First Posted Date

Oct 13, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2023

Last Update Posted Date

Mar 1, 2023Actual

Name	Class
Peking Union Medical College Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Deep Brain Stimulation	Active Comparator	Stimulation is on	Device: Deep Brain Stimulation (DBS) of Gpi Device: Deep Brain Stimulation (DBS) of STN
Placebo	Sham Comparator	Stimulation is off	Device: Deep Brain Stimulation (DBS) of Gpi Device: Deep Brain Stimulation (DBS) of STN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep Brain Stimulation (DBS) of Gpi	Device		Deep Brain Stimulation Placebo	Rechargeable Neurostimulator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Burke-Fahn-Marsden Scale (BFM)		Change from baseline in BMF at 1, 3 months and 6 months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Li Luming, PhD	Tsinghua University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking union medical college hospital		Beijing	Beijing Municipality	100032	China

Condition Browse Module

MeSH Terms

ID	Term
D004421	Dystonia

Ancestor Terms

ID	Term
D020820	Dyskinesias
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D046690	Deep Brain Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided