NCT02263430

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 14, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

September 28, 2014

Last Update Submit

October 13, 2016

Conditions

Huntington's Disease

Outcome Measures

Primary Outcomes (1)

  • Unified Huntington's Disease Rating Scale(UHDRS)

    12 month

Study Arms (2)

Deep Brain Stimulation

EXPERIMENTAL

Stimulation is on.

Device: Deep Brain Stimulation

Placebo

SHAM COMPARATOR

Stimulation is off.

Device: Deep Brain Stimulation

Interventions

Deep Brain StimulationDEVICE
Also known as: Rechargeable Neurostimulator
Deep Brain StimulationPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject clinically symptomatic and genetically confirmed Huntington Disease (number of CAG repeats\>= 36)
  • Moderate stage of the disease (UHDRS motor\>= 30)
  • Predominant movement disorder
  • Signed informed consent.

You may not qualify if:

  • Patients with hearing impairment;
  • Failures of important organs and in severe conditions;
  • Be reluctant or disabled to receive neuropsychological assessments;
  • Participate in other clinical trial;
  • Has a life expectancy of \< 1 year.
  • The investigator and/or enrollment review committee, would preclude participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Huntington Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Li Luming, PhD

    Tsinghua University

    STUDY CHAIR

Central Study Contacts

Jia Fumin, PhD

CONTACT

010-59361265pins_medical@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2014

First Posted

October 13, 2014

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 14, 2016

Record last verified: 2016-08