Deep Brain Stimulation Treatment for Chorea in Huntington's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
研究概览
简要总结
- 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
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 for the 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
结局指标
主要结局
Unified Huntington's Disease Rating Scale（UHDRS）-total score difference
时间窗: 6 months postoperatively compared with baseline
Difference in the UHDRS total score at 6 months postoperative compared with baseline
次要结局
- electrophysiology(3 to 5 days postoperative)
- EuroQol five dimensions questionnaire (EQ-5D) difference(6 months postoperatively compared with baseline)
- UHDRS-Chorea subscore difference(6 months postoperatively compared with baseline)
- Neuroimage(preoperative, 3 months and 6 months postoperative)
- Mental Behavior Rating Scale difference(6 months postoperatively compared with baseline)
研究者
Zhang Jianguo
Director of functional neurosurgery in Beijing Tiantan Hospital
Beijing Tiantan Hospital