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

Sponsor
Beijing Pins Medical Co., Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02263430
Collaborator
Beijing Tiantan Hospital (Other)
8
Enrollment
2
Arms
24
Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Deep Brain Stimulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease
Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Deep Brain Stimulation

Stimulation is on.

Device: Deep Brain Stimulation
Other Names:
  • Rechargeable Neurostimulator

    		•
    Sham Comparator: Placebo

    Stimulation is off.

    Device: Deep Brain Stimulation
    Other Names:
  • Rechargeable Neurostimulator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Unified Huntington's Disease Rating Scale(UHDRS) [12 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Beijing Pins Medical Co., Ltd
    • Beijing Tiantan Hospital

    Investigators

    • Study Chair: Li Luming, PhD, Tsinghua University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beijing Pins Medical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT02263430
    Other Study ID Numbers:
    • PINS-007
    First Posted:
    Oct 13, 2014
    Last Update Posted:
    Oct 14, 2016
    Last Verified:
    Aug 1, 2016
    Additional relevant MeSH terms:
    Huntington Disease

    Study Results

    No Results Posted as of Oct 14, 2016