RecruitingNot ApplicableNCT07277309

Promoting Recovery After Brain Injury Using Focused Ultrasound


Sponsor

Massachusetts General Hospital

Enrollment

36 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 79 Years

Inclusion Criteria3

  • Brain injury resulting in DoC diagnosis, following international guidelines
  • At least 18 years of age
  • Legally authorized representative (surrogate) available to consent

Exclusion Criteria5

  • 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

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Interventions

DEVICELow-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

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NCT07277309


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