Deep Brain Stimulation Treatment for Chorea in Huntington's Disease

Huntington Disease Clinical Trial

Official title:

Deep Brain Stimulation Treatment for Chorea in Huntington's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04244513
• Other study ID #: KY2019-092-03
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2022
• Source: Beijing Municipal Administration of Hospitals
• Contact: Yiying Li, M.D.
• Phone: +86-59975612
• Email: yyli888[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chorea
• Deep Brain Stimulation
• Huntington Disease

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Municipal Administration of Hospitals	Medtronic

Country where clinical trial is conducted

China, 

Outcome

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