Deep Brain Stimulation Treatment for Chorea in Huntington's Disease

Phase

N/A

Condition

Dyskinesias

Dystonia

Treatment

N/A

Clinical Study ID

NCT04244513

KY2019-092-03

Ages 30-60
All Genders

Study Summary

Evaluating therapeutic effects of globus pallidus internus (GPi) deep brain stimulation (DBS) on Huntington's disease (HD) patients with chorea；
Explore the relationship between brain network conditions and DBS efficacy in HD patients
Explore the effect of different programmed parameters on the treatment of patients with DBS

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

February 01, 2020

December 30, 2023

Study Description

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.

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.

Connect with a study center

Beijing Tiantan Hospital
Beijing, Beijing 100070
China
Active - Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
China
Site Not Available
West China Hospital, Sichuan University
Chengdu, Sichuan
China
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.