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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 : 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

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
Huntington's Disease Device: Deep Brain Stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deep Brain Stimulation
Stimulation is on.
Device: Deep Brain Stimulation
Other Name: Rechargeable Neurostimulator

Sham Comparator: Placebo
Stimulation is off.
Device: Deep Brain Stimulation
Other Name: Rechargeable Neurostimulator




Primary Outcome Measures :
  1. Unified Huntington's Disease Rating Scale(UHDRS) [ Time Frame: 12 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02263430


Contacts
Contact: Jia Fumin, PhD 010-59361265 pins_medical@163.com

Sponsors and Collaborators
Beijing Pins Medical Co., Ltd
Beijing Tiantan Hospital
Investigators
Study Chair: Li Luming, PhD Tsinghua University

Responsible Party: Beijing Pins Medical Co., Ltd
ClinicalTrials.gov Identifier: NCT02263430     History of Changes
Other Study ID Numbers: PINS-007
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Chorea
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Dyskinesias
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders