Focused Ultrasound for Disorders of Consciousness

(ReBOUND Trial)

Not yet recruiting at 1 trial location

Overseen By Jason Lew, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for patients who have severe brain injuries and are not fully recovering, leading to conditions like coma or vegetative state. It's aimed at those with altered consciousness due to injury or stroke.

Inclusion Criteria

I have been diagnosed with a disorder of consciousness after a brain injury.

I am 18 years old or older.

Legally authorized representative (surrogate) available to consent

Exclusion Criteria

Pregnancy

History of neurological disorder other than the brain injury

Metal implant or other condition precluding MRI

What Are the Treatments Tested in This Trial?

Interventions

• Low-intensity focused ultrasound

Trial Overview The study tests low-intensity focused ultrasound (LIFUP) as a treatment to promote recovery in patients with disorders of consciousness after brain injury. It will assess behavioral and EEG responses, along with ethical perspectives from patient representatives.

How Is the Trial Designed?

Group I: LIFUP group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+