Promoting Recovery After Brain Injury Using Focused Ultrasound
NCT ID: NCT07277309
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2025-12-31
2029-07-31
Brief Summary
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Detailed Description
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Aim 3: Identify and evaluate ethical perspectives of patient representatives (family members and surrogate decision-makers) surrounding investigation of therapeutic neuromodulation technologies such as LIFUP in patients with DoC.
Advanced MRI will be obtained to determine predictive neuroimaging signatures of responsiveness. This project will crucially inform the groundwork for a personalized, connectome-based approach to impactful therapeutic intervention for patients affected by DoC due to diverse pathologies across the brain injury care continuum and will inform an ethical framework for responsible development and deployment of therapeutic neuromodulation technologies.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LIFUP group
Participants will receive low-intensity focused ultrasound intervention. Participants are also anticipated to undergo advanced MRI and EEG. Surrogate decision makers (family members) and recovered patients will undergo a semi-structured interview.
Low-intensity focused ultrasound
Low-intensity focused ultrasound pulsations (LIFUP) will be delivered to the brain, along with advanced MRI and EEG. Surrogate decision makers (family members) and recovered patients will undergo a semi-structured interview.
Interventions
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Low-intensity focused ultrasound
Low-intensity focused ultrasound pulsations (LIFUP) will be delivered to the brain, along with advanced MRI and EEG. Surrogate decision makers (family members) and recovered patients will undergo a semi-structured interview.
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* Legally authorized representative (surrogate) available to consent
Exclusion Criteria
* Metal implant or other condition precluding MRI
* Manifest continuous spontaneous movement (which would prevent safe/successful MRI)
* Participation in concurrent therapeutic study
* Pregnancy
18 Years
79 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Michael J. Young, M.D., M.Phil
PI
Locations
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Massachusetts General Hospital (The General Hospital Corp.)
Boston, Massachusetts, United States
Spaulding Rehabilitation Hospital Corporation, Inc.
Cambridge, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025P002816
Identifier Type: -
Identifier Source: org_study_id
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