Deep Brain Stimulation Treatment for Chorea in Huntington's Disease

Not Applicable

• Conditions: Huntington Disease; Deep Brain Stimulation
• Interventions: Device: Deep brain stimulation

• Registration Number: NCT04244513
• Lead Sponsor: Beijing Municipal Administration of Hospitals

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

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 Timeline

• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-25
• Study First Posted: 2020-01-28
• Study Start: 2020-02-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-20
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HD-DBS	Deep brain stimulation	This group will be routinely activated after surgery and then stimulated for 6 months.
HD-sham-DBS	Deep brain stimulation	This group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months

Primary Outcome Measures

Name	Time	Method
Unified Huntington's Disease Rating Scale（UHDRS）-total score difference	6 months postoperatively compared with baseline	Difference in the UHDRS total score at 6 months postoperative compared with baseline

Secondary Outcome Measures

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

Trial Locations

Locations (3)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China