Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Disorders of Consciousness
2026年7月2日 更新者：Dr. Benjamin Davidson、Sunnybrook Health Sciences Centre
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
10
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Benjamin Davidson, MD, PhD
- 电话号码：80093 (416) 480-6100
- 邮箱：benjamin.davidson@sunnybrook.ca
研究联系人备份
- 姓名：Jaana Leppala, Masters of Neuroscience
- 电话号码：6476852284
- 邮箱：jaana.leppala@sunnybrook.ca
学习地点
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Ontario
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Toronto、Ontario、加拿大、M4N 3M5
- 招聘中
- Sunnybrook Health Sciences Centre
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接触：
- Benjamin Davidson, MD, PhD
- 电话号码：80093 (416) 480-6100
- 邮箱：benjamin.davidson@sunnybrook.ca
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接触：
- Nir Lipsman, MD, PHD, FRCSC, FAANS
- 电话号码：(416)-480-6954
- 邮箱：Nir.Lipsman@sunnybrook.ca
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Focused Ultrasound Neuromodulation
Participants will receive two sessions of MRI-guided low-intensity focused ultrasound (FUS) neuromodulation using the FUS Next Generation Dome Helmet (NGDH), targeting the bilateral centromedian and parafascicular nuclei of the thalamus.
Treatments will be spaced four weeks apart, plus or minus one week.
All participants will receive the same intervention and will be followed for safety, feasibility, clinical outcomes, and neurophysiological effects, including follow-up through 12 weeks after the second treatment and additional assessments at 12 months post-injury when feasible.
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Participants will receive MR-guided focused ultrasound neuromodulation using the Next Generation Dome Helmet (NGDH).
Each participant will undergo two treatment sessions spaced four weeks apart.
MRI and CT imaging will be used to guide targeting of the bilateral centromedian/parafascicular nuclei of the thalamus.
Continuous monitoring will be performed during each session, and follow-up clinical, EEG, and MRI assessments will be conducted to evaluate safety, feasibility, and preliminary effects.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility of Bilateral Central Thalamic FUS Neuromodulation
大体时间：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.
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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.
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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.
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Safety of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients with Disorders of Consciousness
大体时间：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.
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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.
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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.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Behavioral Responsiveness (Coma Recovery Scale-Revised, CRS-R)
大体时间：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.
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The Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment used to measure level of consciousness in patients with disorders of consciousness.
The CRS-R consists of 6 subscales (Auditory, Visual, Motor, Oromotor/Verbal, Communication, and Arousal) that evaluate reproducible signs of awareness.
Total scores range from 0 to 23, with higher scores indicating greater behavioral responsiveness and higher levels of consciousness.
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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.
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Change in Glasgow Coma Scale (GCS)
大体时间：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.
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The Glasgow Coma Scale (GCS) is a standardized clinical tool used to assess a patient's level of consciousness, particularly after brain injury. It evaluates three components of responsiveness: eye opening, verbal response, and motor response. Each component is scored individually and then summed to produce a total score ranging from 3 to 15. Higher scores indicate better neurological function and greater levels of consciousness, while lower scores reflect more severe impairment. |
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.
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Change in Rancho Los Amigos Scale Level
大体时间：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.
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The Rancho Los Amigos Scale (also known as the Rancho Los Amigos Levels of Cognitive Functioning Scale) is an 8-level clinical scale used to assess cognitive recovery and behavioral responsiveness following severe brain injury.
The scale ranges from Level I (No Response) to Level VIII (Purposeful and Appropriate Response).
Higher levels indicate greater cognitive functioning, improved awareness, and more appropriate and consistent behavioral responses.
Only participants who scored 23 on CRS-R will complete The Rancho Los Amigos Scale.
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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.
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Change in EEG Measures of Neural Activity
大体时间：Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.
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Electroencephalography (EEG) will be used to assess changes in neural activity before and after focused ultrasound (FUS) neuromodulation. EEG measures will include spectral power (frequency band power across delta, theta, alpha, beta, and gamma ranges), spectral entropy (a measure of signal complexity and cortical activation), and event-related responses during task-based paradigms (e.g., motor imagery and passive auditory language tasks). Higher spectral entropy and increased task-related cortical responses are generally interpreted as reflecting greater cortical activation and improved network engagement associated with arousal and awareness. Changes in resting-state spectral power and task-evoked responses will be assessed relative to baseline. |
Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.
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Change in Resting-State Functional Connectivity (rs-fMRI)
大体时间：Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.
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Resting-state functional MRI will be used to assess changes in resting-state functional connectivity between the central thalamus and frontal/parietal cortical regions.
Connectivity may be quantified using seed-based connectivity metrics and network-level connectivity measures derived from resting-state data.
Changes will be assessed relative to baseline.
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Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.
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Change in Task-Based Functional Connectivity
大体时间：Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.
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Task-based functional MRI will be used to assess brain activation and network engagement during structured paradigms, such as motor imagery and passive auditory language tasks.
Task-related blood-oxygen-level-dependent (BOLD) responses will be used to assess regional brain activation and network-level engagement.
Changes will be assessed relative to baseline.
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Assessed at Baseline, 2 weeks after each treatment and 1 year follow-up.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年9月10日
初级完成 (估计的)
2027年9月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年7月2日
首先提交符合 QC 标准的
2026年7月2日
首次发布 (实际的)
2026年7月9日
研究记录更新
最后更新发布 (实际的)
2026年7月9日
上次提交的符合 QC 标准的更新
2026年7月2日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.