Promoting Recovery After Brain Injury Using Focused Ultrasound
Purpose
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.
Conditions
- Consciousness Disorders
- Disorders of Consciousness Due to Severe Brain Injury
Eligibility
- Eligible Ages
- Between 18 Years and 79 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
Recruiting Locations
Boston 4930956, Massachusetts 6254926 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed 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.