Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04244513
Other study ID # KY2019-092-03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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 choreaï¼› 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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Not yet recruiting NCT04429230 - Non-invasive Brain Stimulation in Huntington's Disease N/A
Recruiting NCT05032196 - Study of WVE-003 in Patients With Huntington's Disease Phase 1/Phase 2
Recruiting NCT03599076 - Wearable Sensors for Quantitative Assessment of Motor Impairment in Huntington's Disease Huntington's Disease
Terminated NCT04617860 - Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease Phase 1/Phase 2
Completed NCT05748288 - Development of the Virtual Unified Huntington's Disease Rating Scale
Not yet recruiting NCT05360082 - Comparison Between [11C]UCB-J and [18F]SynVest-1 PET in HD.
Not yet recruiting NCT04370470 - Development of Assessments for Later Stage HD
Recruiting NCT01834053 - Safety and Efficacy of Bone Marrow Derived MNCs for Treatment of Cells for the Treatment of Hunting Tons Chorea. Phase 1/Phase 2
Completed NCT01357681 - Effects of EGCG (Epigallocatechin Gallate) in Huntington's Disease (ETON-Study) Phase 2
Completed NCT01458470 - A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease Phase 2
Completed NCT00980694 - Bioavailability of Ubiquinol in Huntington Disease Phase 1
Completed NCT00146211 - TREND-HD - A Trial of Ethyl-EPA (Miraxionâ„¢) in Treating Mild to Moderate Huntington's Disease Phase 3
Recruiting NCT01412125 - Study of Biomarkers That Predict the Evolution of Huntington's Disease N/A
Completed NCT00075140 - Family Health After Predictive Huntington Disease (HD) Testing Phase 3
Recruiting NCT04818060 - Preparing for Prevention of Huntington's Disease (PREVENT-HD)
Active, not recruiting NCT04698551 - NIPD on cffDNA for Triplet Repeat Diseases
Not yet recruiting NCT04301726 - Efficacy of Deutetrabenazine to Control Symptoms of Dysphagia Associated With HD Phase 1
Completed NCT03421327 - Genetic Risk: Whether, When, and How to Tell Adolescents
Recruiting NCT03296176 - Metabolomic Study in Huntington's Disease (METABO-HD) N/A