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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HD-DBS | Experimental | This group will be routinely activated after surgery and then stimulated for 6 months. |
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| HD-sham-DBS | Sham Comparator | This group of patients will be re-launched 3 months after surgery, continued stimulation for 3 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| UHDRS-Chorea subscore difference | Difference in the UHDRS chorea subscore at 6 months postoperative compared with baseline | 6 months postoperatively compared with baseline |
| Mental Behavior Rating Scale difference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yiying Li, M.D. | Contact | +86-59975612 | yyli888@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianguo Zhang, Ph.D | Beijing Tiantan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| D002819 | Chorea |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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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.
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This study adopts a blind design. One day before the first programming, the grouper and the programmer will release the cover independently. Only the grouper and the programmer will know the group information of each patient, in which the programmer does not communicate with the patient about the programming parameters. After each programming, the results are uniformly placed in the programmer to keep the others (patients, neurologists) blind about grouping and parameters. The evaluation will be finished by neurologists and video records of the patient's motor assessment. Neurologists do not participate in the surgical treatment and programmer. The statistical team is independent of other researchers. When performing statistical analysis, only the group information is known, the programming parameters corresponding to the group are blinded. The Medtronic company only provides equipment support and does not participate in any clinical research process.
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the total score of MMSE at 6 months postoperative compared with baseline
| 6 months postoperatively compared with baseline |
| Mental Behavior Rating Scale difference | the total score of BDI at 6 months postoperative compared with baseline | 6 months postoperatively compared with baseline |
| 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 |
| Neuroimage | MRI | preoperative, 3 months and 6 months postoperative |
| electrophysiology | EEG and Local field potential (LFP) of GPi and GPe in patients with Huntington's Disease | 3 to 5 days postoperative |
| The First Affiliated Hospital of Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
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| West China Hospital, Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
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| D003704 | Dementia |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |