Deep Brain Stimulation Treatment for Chorea in Huntington's Disease

July 18, 2022 updated by: Zhang Jianguo, Beijing Municipal Administration of Hospitals
  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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

1. Evaluating therapeutic effects of GPi-DBS on HD patients with chorea: Clinical data of patients at different treatment time points will be collected, using different clinical assessments. The clinical case report form for HD-DBS is consistent with Enroll HD project and the case report form is attached in the appendix. The main purpose is to determine the efficiency of DBS treatment for HD with chorea by comparing the patients' status before and after surgery.

Primary endpoints: Changes in chorea score of UHDRS, changes in total motor score (UHDRS).

Secondary endpoints: changes in cognition will be assessed by stroop interference test, stroop word reading test, stroop colour naming test, trail making test, symbol digit modality test and mini-mental state examination(MMSE); changes in anxiety assessed by Hamilton Anxiety Scale(HAMA); changes in depression assessed by Hamilton depression scale(HAMD) and Beck Depression Inventory (BDI); changes in the frequency and severity of neuropsychiatric symptoms assessed by the Problem Behaviours Assessment for HD and changes in quality-of-life assessed by UHDRS functional assessment and UHDRS total functional capacity assessment.

2 Explore the relationship between brain network conditions and DBS efficacy in HD patients The electrophysiological signals during the operation of HD patients will be collected and analyzed, and compared with the postoperative disease conditions, to determine the relationship between the patient's EEG activity and the mechanism of disease development, disease progression, and treatment effect.

3. Explore the effect of different programmed parameters on the treatment of patients with DBS After the HD patient is turned on, the patient is programmed to adjust the program control parameters of different patients during adjustment, and the effects of different program control parameters on the patient, tolerance, and related side effects are clarified.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yue Huang, Ph.D
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Huntington's Disease disgnosis by gene
  2. Predominant chorea
  3. UHDRS score ≥30
  4. Mini-Mental State Examination (MMSE) score meets the education level
  5. No plan to change medication within 12 months after randomization
  6. Agree to enroll into the clinical trial

Exclusion Criteria:

  1. Chorea caused by other diseases
  2. Concurrently or previously had other neurological disorders
  3. Severe psychiatric disease
  4. Unstable condition or severe heart, lung, liver, kidney, or hematopoietic diseases
  5. Have a history of cancer unless it has been cured or does not require treatment for the next 5 years
  6. Contraindications to an MRI scan
  7. Acute psychiatric symptomatology in the last 2 months including suicide ideation, angry or aggressive behaviour, and hallucinations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HD-DBS
This group will be routinely activated after surgery and then stimulated for 6 months.
Device: Deep brain stimulation
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.
Sham Comparator: HD-sham-DBS
This group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months
Device: Deep brain stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
Time Frame: 3 months postoperatively compared between groups
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
Time Frame: 6 months postoperatively compared with baseline
Difference in the UHDRS total score at 6 months postoperative compared with baseline
6 months postoperatively compared with baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
UHDRS-Chorea subscore difference
Time Frame: 6 months postoperatively compared with baseline
Difference in the UHDRS chorea subscore at 6 months postoperative compared with baseline
6 months postoperatively compared with baseline
Mental Behavior Rating Scale difference
Time Frame: 6 months postoperatively compared with baseline
the total score of MMSE at 6 months postoperative compared with baseline
6 months postoperatively compared with baseline
Mental Behavior Rating Scale difference
Time Frame: 6 months postoperatively compared with baseline
the total score of BDI at 6 months postoperative compared with baseline
6 months postoperatively compared with baseline
EuroQol five dimensions questionnaire (EQ-5D) difference
Time Frame: 6 months postoperatively compared with baseline
the total score of EQ-5D at 6 months postoperative compared with baseline
6 months postoperatively compared with baseline
Neuroimage
Time Frame: preoperative, 3 months and 6 months postoperative
MRI
preoperative, 3 months and 6 months postoperative
electrophysiology
Time Frame: 3 to 5 days postoperative
EEG and Local field potential (LFP) of GPi and GPe in patients with Huntington's Disease
3 to 5 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Municipal Administration of Hospitals

Collaborators

Medtronic

Investigators

  • Study Chair: Jianguo Zhang, Ph.D, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 25, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2019-092-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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