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

NCT ID: NCT02263430

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Huntington's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Deep Brain Stimulation

Stimulation is on.

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Placebo

Stimulation is off.

Group Type SHAM_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

Interventions

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Deep Brain Stimulation

Intervention Type DEVICE

Other Intervention Names

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Rechargeable Neurostimulator

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Luming, PhD

Role: STUDY_CHAIR

Tsinghua University

Central Contacts

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Jia Fumin, PhD

Role: CONTACT

010-59361265

Other Identifiers

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PINS-007

Identifier Type: -

Identifier Source: org_study_id

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