Deep Brain Stimulation Treatment for Chorea in Huntington's Disease
1 other identifier
interventional
40
1 country
3
Brief Summary
- 1.Evaluating therapeutic effects of globus pallidus internus (GPi) deep brain stimulation (DBS) on Huntington's disease (HD) patients with chorea；
- 2.Explore the relationship between brain network conditions and DBS efficacy in HD patients
- 3.Explore the effect of different programmed parameters on the treatment of patients with DBS
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
Longer than P75 for not_applicable
3 active sites
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
January 17, 2020
CompletedFirst Posted
Study publicly available on registry
January 28, 2020
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedJuly 20, 2022
July 1, 2022
3.4 years
January 17, 2020
July 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
Difference between groups in the UHDRS total score at 3 months postoperative；from 0 to 124 points; the higher scores mean a worse outcome
3 months postoperatively compared between groups
Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
Difference in the UHDRS total score at 6 months postoperative compared with baseline
6 months postoperatively compared with baseline
Secondary Outcomes (6)
UHDRS-Chorea subscore difference
6 months postoperatively compared with baseline
Mental Behavior Rating Scale difference
6 months postoperatively compared with baseline
Mental Behavior Rating Scale difference
6 months postoperatively compared with baseline
EuroQol five dimensions questionnaire (EQ-5D) difference
6 months postoperatively compared with baseline
Neuroimage
preoperative, 3 months and 6 months postoperative
- +1 more secondary outcomes
Study Arms (2)
HD-DBS
EXPERIMENTALThis group will be routinely activated after surgery and then stimulated for 6 months.
HD-sham-DBS
SHAM COMPARATORThis group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months
Interventions
the HD-DBS arm will be routinely activated after surgery and then stimulated for 6 months(6 months stimulation). The HD-shamDBS arm will be re-launched 3 months after surgery, continued stimulation for 3 months(3 months stimulation), and then entered the open study.
Eligibility Criteria
You may qualify if:
- Huntington's Disease disgnosis by gene
- Predominant chorea
- UHDRS score ≥30
- Mini-Mental State Examination (MMSE) score meets the education level
- No plan to change medication within 12 months after randomization
- Agree to enroll into the clinical trial
You may not qualify if:
- Chorea caused by other diseases
- Concurrently or previously had other neurological disorders
- Severe psychiatric disease
- Unstable condition or severe heart, lung, liver, kidney, or hematopoietic diseases
- Have a history of cancer unless it has been cured or does not require treatment for the next 5 years
- Contraindications to an MRI scan
- Acute psychiatric symptomatology in the last 2 months including suicide ideation, angry or aggressive behaviour, and hallucinations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Municipal Administration of Hospitalslead
- Medtroniccollaborator
Study Sites (3)
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianguo Zhang, Ph.D
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This study adopts a blind design. One day before the first programming, the grouper and the programmer will release the cover independently. Only the grouper and the programmer will know the group information of each patient, in which the programmer does not communicate with the patient about the programming parameters. After each programming, the results are uniformly placed in the programmer to keep the others (patients, neurologists) blind about grouping and parameters. The evaluation will be finished by neurologists and video records of the patient's motor assessment. Neurologists do not participate in the surgical treatment and programmer. The statistical team is independent of other researchers. When performing statistical analysis, only the group information is known, the programming parameters corresponding to the group are blinded. The Medtronic company only provides equipment support and does not participate in any clinical research process.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of functional neurosurgery in Beijing Tiantan Hospital
Study Record Dates
First Submitted
January 17, 2020
First Posted
January 28, 2020
Study Start
February 1, 2020
Primary Completion
June 30, 2023
Study Completion
December 30, 2023
Last Updated
July 20, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share