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

Beijing Pins Medical

Status: Unknown

Conditions: Huntington's Disease

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02263430

PINS-007

Details and patient eligibility

About

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).

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups

Deep Brain Stimulation

Experimental group

Description:

Stimulation is on.

Treatment:

Device: Deep Brain Stimulation

Placebo

Sham Comparator group

Description:

Stimulation is off.

Treatment:

Device: Deep Brain Stimulation