Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Disorders of Consciousness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Feasibility of Bilateral Central Thalamic FUS Neuromodulation
研究概览
简要总结
The main questions this study aims to answer are:
Can low-intensity FUS neuromodulation be safely and feasibly administered to the bilateral central thalamus in patients with disorders of consciousness (DoC)? Does FUS neuromodulation result in short-term improvements in arousal or behavioral responsiveness? Does FUS neuromodulation produce measurable changes in neural activity on EEG and/or fMRI?
Participants will:
Receive two sessions of low-intensity FUS neuromodulation, spaced four weeks apart, plus or minus one week.
Undergo pre- and post-treatment assessments, including planning CT, MRI/fMRI, EEG, and standardized clinical scales such as the Coma Recovery Scale-Revised (CRS-R) and Glasgow Coma Scale (GCS).
Be continuously monitored for safety during and after each FUS treatment. Complete follow-up imaging and clinical assessments approximately 2 weeks after each FUS session, 12 weeks after the second treatment, and at 12 months post-injury when clinically feasible.
详细描述
This is a prospective, single-center, single-arm, open-label pilot clinical trial. Approximately 10-15 participants are expected to be enrolled. Each participant will receive two sessions of low-intensity focused ultrasound (FUS) neuromodulation targeting the bilateral central thalamus, spaced four weeks apart, plus or minus one week. Participants will be followed for safety, clinical, imaging, and neurophysiological assessments, including follow-up through 12 weeks after the second treatment and, when clinically feasible, at 12 months post-injury.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of severe traumatic brain injury, hypoxic-ischemic brain injury, or other acute brain injury.
- •Glasgow coma scale below 13 when off sedation, or on minimal sedation.
- •Absence of another better explanation for the depressed level of consciousness (e.g,, metabolic abnormality, seizures)
- •Intracranial pressure (ICP) is within a normal range (< 20 cm H2O), or, a neurosurgeon associated with the study and/or the treating physician agree that ICP is likely < 20 cm H2O based on clinical and neuroimaging information (acknowledging the limitations of non-invasive assessment of ICP53).
- •The treating physician and/or neurosurgeon associated with the study evaluate it to be safe for the patient to be transported to the MRI scanner for a ~45 minute scan.
排除标准
- •Active seizure activity or post-anoxic myoclonus at the time of proposed treatment
- •Taking full anti-coagulation medication (does not include deep-vein-thrombosis chemoprophylaxis)
- •Skull anatomy incompatible with safe FUS delivery (as determined by CT)
- •Medical instability that would preclude safe transport or prolonged supine positioning
- •Presence of any MRI-incompatible implants or devices
结局指标
主要结局
Feasibility of Bilateral Central Thalamic FUS Neuromodulation
时间窗: Assessed at Screening/Baseline, Treatment 1, Mid-treatment assessment (2 weeks after Treatment 1), Treatment 2 (4 weeks after Treatment 1), 2-week follow-up (2 weeks after each treatment), 12 weeks after Treatment 2, and 1-year follow-up.
Feasibility will be defined as the proportion of enrolled participants who complete both focused ultrasound (FUS) neuromodulation sessions without protocol deviation or occurrence of a serious adverse event (SAE) related to the procedure.
Safety of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients with Disorders of Consciousness
时间窗: Assessed at Screening/Baseline, Treatment 1, Mid-treatment assessment (2 weeks after Treatment 1), Treatment 2 (4 weeks after Treatment 1), 2-week follow-up (2 weeks after each treatment), 12 weeks after Treatment 2, and 1-year follow-up.
Safety will be assessed by the frequency, type, and severity of adverse events (AEs) and serious adverse events (SAEs) following FUS treatment. Events of interest include seizures, autonomic instability, new focal neurological deficits, clinical deterioration, or structural abnormalities detected on post-treatment MRI.
次要结局
- Change in Behavioral Responsiveness (Coma Recovery Scale-Revised, CRS-R)(Assessed at Baseline, Treatment 1, Mid-treatment assessment (2 weeks after Treatment 1), Treatment 2 (4 weeks after Treatment 1), 2-week follow-up (2 weeks after each treatment), 12 weeks after Treatment 2, and 1-year follow-up.)
- Change in Glasgow Coma Scale (GCS)(Assessed at Baseline, Treatment 1, Mid-treatment assessment (2 weeks after Treatment 1), Treatment 2 (4 weeks after Treatment 1), 2-week follow-up (2 weeks after each treatment), 12 weeks after Treatment 2, and 1-year follow-up.)
- Change in Rancho Los Amigos Scale Level(Assessed at Baseline, Treatment 1, Mid-treatment assessment (2 weeks after Treatment 1), Treatment 2 (4 weeks after Treatment 1), 2-week follow-up (2 weeks after each treatment), 12 weeks after Treatment 2, and 1-year follow-up.)
- Change in EEG Measures of Neural Activity(Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.)
- Change in Resting-State Functional Connectivity (rs-fMRI)(Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.)
- Change in Task-Based Functional Connectivity(Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.)
研究者
Dr. Benjamin Davidson
Principal Investigator
Sunnybrook Health Sciences Centre