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

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ClinicalTrials.gov Identifier: NCT02263430
Recruitment Status : Unknown
Verified August 2016 by Beijing Pins Medical Co., Ltd.
Recruitment status was:  Not yet recruiting
First Posted : October 13, 2014
Last Update Posted : October 14, 2016
Sponsor:
Collaborator:
Beijing Tiantan Hospital
Information provided by (Responsible Party):
Beijing Pins Medical Co., Ltd

Tracking Information
First Submitted Date  ICMJE September 28, 2014
First Posted Date  ICMJE October 13, 2014
Last Update Posted Date October 14, 2016
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 8, 2014)
Unified Huntington's Disease Rating Scale(UHDRS) [ Time Frame: 12 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02263430 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease
Official Title  ICMJE PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE Device: Deep Brain Stimulation
Other Name: Rechargeable Neurostimulator
Study Arms  ICMJE
  • Experimental: Deep Brain Stimulation
    Stimulation is on.
    Intervention: Device: Deep Brain Stimulation
  • Sham Comparator: Placebo
    Stimulation is off.
    Intervention: Device: Deep Brain Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 8, 2014)
8
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02263430
Other Study ID Numbers  ICMJE PINS-007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Pins Medical Co., Ltd
Study Sponsor  ICMJE Beijing Pins Medical Co., Ltd
Collaborators  ICMJE Beijing Tiantan Hospital
Investigators  ICMJE
Study Chair: Li Luming, PhD Tsinghua University
PRS Account Beijing Pins Medical Co., Ltd
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP