Promoting Recovery After Brain Injury Using Focused Ultrasound

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07277309
Status
Recruiting
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Conditions

  • Consciousness Disorders
  • Disorders of Consciousness Due to Severe Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Low-intensity focused ultrasound — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Determine neurobehavioral responses to LIFUP in patients with DoC: Coma Recovery Scale - Revised (CRS-R) [ Time Frame: Days 1-3 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital (The General Hospital Corp.)BostonMassachusetts02114
Michael Young, MD, MPhil
[email protected]
410-808-1196
Michael Young, MD, MPhil (PRINCIPAL_INVESTIGATOR)
Spaulding Rehabilitation Hospital Corporation, Inc.CambridgeMassachusetts02138
Jason Lew, DO
[email protected]
617-724-9247
Jason Lew, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital (The General Hospital Corp.)· Boston, MASpaulding Rehabilitation Hospital Corporation, Inc.· Cambridge, MA

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