Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Occurence of all SAEs and AEs that are deemed related or possibly related to study procedure or to study investigational system, from implantation up to the end of the study
研究概览
简要总结
The purpose of this study is to evaluate safety of Deep Brain Stimulation (DBS) of the lateral hypothalamus (LH) and whether the use of DBS can increase motor performance in patients with chronic spinal cord injury (SCI). The hypothesis, based on preclinical findings, is that DBS of the lateral hypothalamus can acutely augment leg motor function after SCI, and that the use of lateral hypothalamus DBS can be an adjunct during rehabilitation to promote recovery and long-term neuroplasticity.
详细描述
The investigators hypothesize that deep brain stimulation (DBS) delivered in the lateral hypothalamus (LH) can augment leg motor function in humans with SCI. DBS is a well-established neurosurgical technique that is used routinely in humans. For example, DBS is commonly used to regulate the activity of basal ganglia circuits in order to treat movement disorders like Parkinson's disease or tremor. For the past decade, the hypothalamus has been safely targeted to treat diseases such as obesity and cluster headache.
In this study, The investigators propose to test the safety and preliminary efficacy of Lateral Hypothalamus DBS in 3 individuals with incomplete SCI, as a potential basis for larger clinical trials. The investigators anticipate that such clinical trials will evaluate the respective impact of, and potential synergy between, DBS of the lateral hypothalamus and epidural electrical stimulation of the lumbar spinal cord to augment recovery from SCI.
The study intervention consists of 7 phases preceded by pre-screening:
- Screening and enrolment
- Baseline - Pre-implantation
- Surgery
- Calibration
- Pre-rehabilitation
- Rehabilitation
- Post-rehabilitation
- (Optional and conditional): safety follow-up period
Measures will be performed before surgical intervention, after surgery but before training (Pre-rehabilitation), at regular intervals during training and at the end of the training phase (post-rehabilitation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SCI graded as American Spinal Injury Association Impairment Scale (AIS) C or D (able to walk independently for a few meters with a walker)
- •Focal spinal cord disorder caused by trauma
- •Minimum 12 months post-injury
- •Stable medical, physical and psychological condition as considered by Investigators
- •Able to understand and interact with the study team in French or English
- •Adequate care-giver support and access to appropriate medical care in patient's home community
- •Must agree to comply in good faith with all conditions of the study and to attend all required study training and visit
- •Must provide and sign Informed Consent prior to any study related procedures
排除标准
- •Limitation of walking function based on accompanying (CNS) disorders (i.e., systemic malignant disorders, cardiovascular disorders restricting physical training, peripheral nerve disorders)
- •History of significant autonomic dysreflexia
- •Cognitive/brain damage
- •Use of an intrathecal baclofen pump
- •Any active implanted cardiac device such as pacemaker or defibrillator
- •Any indication that would require diathermy
- •Increased risk for defibrillation
- •Severe joint contractures disabling or restricting lower limb movements
- •Hematological disorders with increased risk for surgical interventions
- •Congenital or acquired lower limb abnormalities (affection of joints and bone)
- •Women who are pregnant (pregnancy test obligatory for woman of childbearing potential) or breastfeeding
- •Lack of safe contraception for women of childbearing capacity
- •Spinal cord lesion due to either a neurodegenerative disease or a tumor
- •Gastrointestinal ulcers in the last five years
- •Known or suspected eye disorders or diseases
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- •Any other anatomic or co-morbid conditions that, in the Investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Participation in another locomotor training study
- •Refusal to be informed of any finding during the study
结局指标
主要结局
Occurence of all SAEs and AEs that are deemed related or possibly related to study procedure or to study investigational system, from implantation up to the end of the study
时间窗: Through study completion, an average of 6 months
Evaluate the safety of the approach in terms of tolerability of deep brain stimulation of the lateral hypothalamus in patients with chronic spinal cord injury (\> 1 year)
次要结局
- Walking speed (10MWT/6MWT)(Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation)
- Walking Index for Spinal Cord Injury (WISCI II)(Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation)
- Lower Extremity Motor Strength (M0-M5 score according to the AIS scale)(Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation)
研究者
Jocelyne Bloch
Professor, Neurosurgeon
Centre Hospitalier Universitaire Vaudois