Promoting Recovery After Brain Injury Using Focused Ultrasound (ReBOUND)

Mass General Brigham

Status: Not yet enrolling

Conditions: Consciousness Disorders; Disorders of Consciousness Due to Severe Brain Injury

Treatments: Device: Low-intensity focused ultrasound

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07277309

2025P002816

1K23NS140495 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Aim 1: Determine neurobehavioral responses to LIFUP in patients with DoC. Aim 2: Determine neurophysiologic (EEG) responses to LIFUP in patients with DoC.

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

LIFUP group

Experimental group

Description:

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.

Treatment:

Device: Low-intensity focused ultrasound