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

Huntington's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02263430
• Other study ID #: PINS-007
• Status: Not yet recruiting
• Phase: N/A
• First received: September 28, 2014
• Last updated: October 13, 2016
• Start date: December 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Beijing Pins Medical Co., Ltd
• Contact: Jia Fumin, PhD
• Phone: 010-59361265
• Email: pins_medical[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease
• Huntington's Disease

Intervention

Device:
• Deep Brain Stimulation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Huntington's Disease Rating Scale(UHDRS)		12 month	Yes