Clinical trial NCT04244513: Deep Brain Stimulation Treatment for Chorea in Huntington's Disease
Official title: Deep Brain Stimulation Treatment for Chorea in Huntington's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Huntington Disease
Deep Brain Stimulation
Keywords: Deep brain stimulation
Chorea
Huntington Disease
Lead sponsor: Beijing Municipal Administration of Hospitals
Sponsor class: OTHER_GOV
Collaborators: name: Medtronic
First posted: 2020-01-28
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients will be randomized into two groups, of which the first group will be routinely activated after surgery and then stimulated for 6 months. The second group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months, and then entered the open study. Patient data will be collected before surgery, 3 months after surgery, and 6 months after surgery.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
timeFrame: 3 months postoperatively compared between groups
measure: Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
timeFrame: 6 months postoperatively compared with baseline
Secondary outcomes:
measure: UHDRS-Chorea subscore difference
timeFrame: 6 months postoperatively compared with baseline
measure: Mental Behavior Rating Scale difference
timeFrame: 6 months postoperatively compared with baseline
measure: Mental Behavior Rating Scale difference
timeFrame: 6 months postoperatively compared with baseline
measure: EuroQol five dimensions questionnaire (EQ-5D) difference
timeFrame: 6 months postoperatively compared with baseline
measure: Neuroimage
timeFrame: preoperative, 3 months and 6 months postoperative
measure: electrophysiology
timeFrame: 3 to 5 days postoperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Beijing Tiantan Hospital
name: Jianguo Zhang, Ph.D
role: STUDY_CHAIR
References: