Back to resultsPINS Stimulator System for Deep Brain Stimulation in Huntington's Disease
Primary Purpose
Huntington's Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Huntington's Disease
Eligibility Criteria
Inclusion Criteria:
- Subject clinically symptomatic and genetically confirmed Huntington Disease (number of CAG repeats>= 36)
- Moderate stage of the disease (UHDRS motor>= 30)
- Predominant movement disorder
- Compliance of the patient, stable cognition during a 6 months phase prior to inclusion (Mattis Dementia Rating Scales（MDS）>/= 120)
- Signed informed consent.
Exclusion Criteria:
- Patients with hearing impairment;
- Failures of important organs and in severe conditions;
- Be reluctant or disabled to receive neuropsychological assessments;
- Participate in other clinical trial;
- Has a life expectancy of < 1 year.
- The investigator and/or enrollment review committee, would preclude participation in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Deep Brain Stimulation
Placebo
Arm Description
Stimulation is on.
Stimulation is off.
Outcomes
Primary Outcome Measures
Unified Huntington's Disease Rating Scale(UHDRS)
Secondary Outcome Measures
Full Information
NCT ID
NCT02263430
First Posted
September 28, 2014
Last Updated
October 13, 2016
Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02263430
Brief Title
PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease
Official Title
PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Pins Medical Co., Ltd
Collaborators
Beijing Tiantan Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Deep Brain Stimulation (DBS) of the Globus pallidus internus(GPi) is useful in the treatment of different forms of chorea, including Huntington's disease (HD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huntington's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation
Arm Type
Experimental
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
Other Intervention Name(s)
Rechargeable Neurostimulator
Primary Outcome Measure Information:
Title
Unified Huntington's Disease Rating Scale(UHDRS)
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject clinically symptomatic and genetically confirmed Huntington Disease (number of CAG repeats>= 36)
Moderate stage of the disease (UHDRS motor>= 30)
Predominant movement disorder
Compliance of the patient, stable cognition during a 6 months phase prior to inclusion (Mattis Dementia Rating Scales（MDS）>/= 120)
Signed informed consent.
Exclusion Criteria:
Patients with hearing impairment;
Failures of important organs and in severe conditions;
Be reluctant or disabled to receive neuropsychological assessments;
Participate in other clinical trial;
Has a life expectancy of < 1 year.
The investigator and/or enrollment review committee, would preclude participation in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Fumin, PhD
Phone
010-59361265
Email
pins_medical@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Luming, PhD
Organizational Affiliation
Tsinghua University
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease
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