PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease

Not Applicable

• Conditions: Huntington's Disease
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT02263430
• Lead Sponsor: Beijing Pins Medical Co., Ltd

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-28
• Study First Submitted QC: 2014-10-08
• Study First Posted: 2014-10-13
• Status Verified: 2016-08
• Last Update Submitted: 2016-10-13
• Last Update Posted: 2016-10-14
• Study Start: 2016-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1. Subject clinically symptomatic and genetically confirmed Huntington Disease (number of CAG repeats>= 36)
2. Moderate stage of the disease (UHDRS motor>= 30)
3. Predominant movement disorder
4. Compliance of the patient, stable cognition during a 6 months phase prior to inclusion (Mattis Dementia Rating Scales（MDS）>/= 120)
5. Signed informed consent.

Exclusion Criteria

1. Patients with hearing impairment;
2. Failures of important organs and in severe conditions;
3. Be reluctant or disabled to receive neuropsychological assessments;
4. Participate in other clinical trial;
5. Has a life expectancy of < 1 year.
6. The investigator and/or enrollment review committee, would preclude participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Deep Brain Stimulation	Stimulation is off.
Deep Brain Stimulation	Deep Brain Stimulation	Stimulation is on.

Primary Outcome Measures

Name	Time	Method
Unified Huntington's Disease Rating Scale(UHDRS)	12 month