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RECRUITINGINTERVENTIONAL

Promoting Recovery After Brain Injury Using Focused Ultrasound

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Brain injury resulting in DoC diagnosis, following international guidelines - At least 18 years of age - Legally authorized representative (surrogate) available to consent Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

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.

Locations (2)

Massachusetts General Hospital (The General Hospital Corp.)
Boston, Massachusetts, United States
Spaulding Rehabilitation Hospital Corporation, Inc.
Cambridge, Massachusetts, United States