NCT04244513

Deep Brain Stimulation Treatment for Chorea in Huntington's Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Beijing Municipal Administration of Hospitals · Other Government
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Huntington Disease
• Deep Brain Stimulation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-01
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2020-01-28
• Last updated: 2022-07-20

Locations

3 sites across 1 country: China