Promoting Recovery After Brain Injury Using Focused Ultrasound
This study is looking at whether low-intensity focused ultrasound (LIFUP) can help people recover after a severe brain injury that has led to disorders of consciousness (DoC). Researchers will deliver LIFUP to the brain and use advanced MRI (magnetic resonance imaging) and EEG (electroencephalogram, which measures brain activity) to see how patients respond. They will also talk with family members and patients who have recovered to understand their thoughts on this type of treatment. The main goals are to see how patients' behavior and brain activity change after LIFUP. This study is open to adults aged 18 to 79 who have a DoC diagnosis from a brain injury and a legal representative to give consent. It is currently unclear if the study is recruiting.
- Study design
- This is an interventional study planning to enroll 36 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will receive low-intensity focused ultrasound (LIFUP) and undergo advanced MRI and EEG. Neurobehavioral responses will be measured for 1-3 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Neurobehavioral and neurophysiologic responses to LIFUP will be measured at Days 1-3.
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Promoting Recovery After Brain Injury Using Focused Ultrasound
At a glance
Conditions
NCT07277309
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Massachusetts General Hospital (The General Hospital Corp.)
Boston, Massachusettsstudy coordinator listed
Recruiting
Spaulding Rehabilitation Hospital Corporation, Inc.
Cambridge, Massachusettsstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
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Inclusion
Exclusion
What this trial measures
- Determine neurobehavioral responses to LIFUP in patients with DoC: Coma Recovery Scale - Revised (CRS-R)Days 1-3
Outcome measures collected prior to LIFUP sessions will be compared to outcome measures obtained after LIFUP sessions. The Coma Recovery Scale Revised (CRS-R) ranges from 0 to 23 points, with higher scores indicating better neurobehavioral function and level of consciousness. The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level. The lowest score on each sub-scale represents reflexive activity; the highest represents behaviors mediated by cognitive input. The total score ranges between 0 (worst) and 23 (best).
- Determine neurobehavioral responses to LIFUP in patients with DoC: Disability Rating Scale (DRS)Days 1-3
Outcome measures collected prior to LIFUP sessions will be compared to outcome measures obtained after LIFUP sessions. The DRS ranges from 0 to 30 points, with higher scores indicating more severe disability. DRS subscale scores include eye opening \[score range 0-3\], communication \[score range 0-4\], motor response \[score range 0-5\], cognitive ability for feeding \[score range 0-3\], cognitive ability for toileting \[score range 0-3\], cognitive ability for grooming \[score range 0-3\], level of function \[score range 0-5\], and employability \[score range 0-3\]. Subscale scores are summed to produce the total score.
- Determine neurophysiologic responses to LIFUP in patients with DoCDays 1-3
Using electroencephalography (EEG) recordings, we will compute power spectral density within predefined frequency bands and derive ABCD-level classifications, resting-state complexity metrics, and responsiveness indices that quantify the degree of thalamocortical disconnection.
- Identify and evaluate ethical perspectives of patient representatives surrounding investigation of therapeutic neuromodulation technologies such as LIFUP in patients with DoCDays 1-3
Family members or surrogate decision-makers (i.e., legally authorized healthcare proxies of study participants with DoC), will be engaged in interviews to capture their expectations, perspectives, and concerns surrounding the use and deployment of neuromodulation techniques in the context of brain injury. The semi-structured interview will center on key themes: hopes and expectations for neuromodulation technology; views on the informed consent process and data privacy related to neural data; considerations of equity in access to neuromodulation therapies; areas of uncertainty or concern regarding risks and benefits; and perceived roles of caregivers and families in the neuromodulation decision-making process. This approach is designed to elicit a nuanced understanding of ethical considerations as viewed by those most impacted, thereby informing a robust ethical framework that aligns research and clinical practices with the values and needs of patients and their families.