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Recruiting
NCT07277309
Promoting Recovery After Brain Injury Using Focused Ultrasound
Conditions: Consciousness Disorders, Disorders of Consciousness Due to Severe Brain Injury
Sex: All
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital (The General Hospital Corp.) Boston Massachusetts
Summary
The overall aim of this study is to develop an intervention that can help recovery in patients surviving severe brain injury but failing to fully recover. In particular, this project aims to (1) determine neurobehavioral responses to low-intensity focused ultrasound (LIFUP) in patients with disorders of consciousness (DoC) following brain injury, (2) determine neurophysiologic (EEG) responses to LIFUP in patients with DoC and (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.
Eligibility Criteria
Inclusion Criteria:
* Brain injury resulting in DoC diagnosis, following international guidelines
* At least 18 years of age
* Legally authorized representative (surrogate) available to consent
Exclusion Criteria:
* History of neurological disorder other than the brain injury
* Metal implant or other condition precluding MRI
* Manifest continuous spontaneous movement (which would prevent safe/successful MRI)
* Participation in concurrent therapeutic study
* Pregnancy
Source: ClinicalTrials.gov (NCT07277309). StuddyBuddy aggregates publicly available trial information.