Deep Brain Stimulation Treatment for Chorea in Huntington's Disease

Beijing Municipal Administration of Hospitals

Status: Enrolling

Conditions: Huntington Disease; Deep Brain Stimulation

Treatments: Device: Deep brain stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04244513

KY2019-092-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

HD-DBS

Experimental group

Description:

This group will be routinely activated after surgery and then stimulated for 6 months.

Treatment:

Device: Deep brain stimulation

HD-sham-DBS

Sham Comparator group

Description:

This group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months

Treatment:

Device: Deep brain stimulation