Promoting Recovery After Brain Injury Using Focused Ultrasound (ReBOUND)

February 13, 2026 updated by: Michael J. Young, M.D., M.Phil, Massachusetts General Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jason Lew, DO
  • Phone Number: 617-724-9247
  • Email: jlew3@mgb.org

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital (The General Hospital Corp.)
        • Contact:
        • Principal Investigator:
          • Michael Young, MD, MPhil
      • Cambridge, Massachusetts, United States, 02138
        • Recruiting
        • Spaulding Rehabilitation Hospital Corporation, Inc.
        • Principal Investigator:
          • Jason Lew, DO
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Low-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine neurobehavioral responses to LIFUP in patients with DoC: Coma Recovery Scale - Revised (CRS-R)
Time Frame: Days 1-3
Outcome measures collected prior to LIFUP sessions will be compared to outcome measures obtained after LIFUP sessions. The Coma Recovery Scale Revised (CRS-R) ranges from 0 to 23 points, with higher scores indicating better neurobehavioral function and level of consciousness. The CRS-R consists of 6 subscales designed to assess auditory function, receptive and expressive language, visuoperception, communication ability, motor functions, and arousal level. The lowest score on each sub-scale represents reflexive activity; the highest represents behaviors mediated by cognitive input. The total score ranges between 0 (worst) and 23 (best).
Days 1-3
Determine neurobehavioral responses to LIFUP in patients with DoC: Disability Rating Scale (DRS)
Time Frame: Days 1-3
Outcome measures collected prior to LIFUP sessions will be compared to outcome measures obtained after LIFUP sessions. The DRS ranges from 0 to 30 points, with higher scores indicating more severe disability. DRS subscale scores include eye opening [score range 0-3], communication [score range 0-4], motor response [score range 0-5], cognitive ability for feeding [score range 0-3], cognitive ability for toileting [score range 0-3], cognitive ability for grooming [score range 0-3], level of function [score range 0-5], and employability [score range 0-3]. Subscale scores are summed to produce the total score.
Days 1-3
Determine neurophysiologic responses to LIFUP in patients with DoC
Time Frame: Days 1-3
Using electroencephalography (EEG) recordings, we will compute power spectral density within predefined frequency bands and derive ABCD-level classifications, resting-state complexity metrics, and responsiveness indices that quantify the degree of thalamocortical disconnection.
Days 1-3
Identify and evaluate ethical perspectives of patient representatives surrounding investigation of therapeutic neuromodulation technologies such as LIFUP in patients with DoC
Time Frame: Days 1-3
Family members or surrogate decision-makers (i.e., legally authorized healthcare proxies of study participants with DoC), will be engaged in interviews to capture their expectations, perspectives, and concerns surrounding the use and deployment of neuromodulation techniques in the context of brain injury. The semi-structured interview will center on key themes: hopes and expectations for neuromodulation technology; views on the informed consent process and data privacy related to neural data; considerations of equity in access to neuromodulation therapies; areas of uncertainty or concern regarding risks and benefits; and perceived roles of caregivers and families in the neuromodulation decision-making process. This approach is designed to elicit a nuanced understanding of ethical considerations as viewed by those most impacted, thereby informing a robust ethical framework that aligns research and clinical practices with the values and needs of patients and their families.
Days 1-3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain MRI-derived responsiveness index (structural-functional signature predicting LIFUP response)
Time Frame: Day 1
Participants who can safely undergo MRI will receive an advanced brain imaging protocol. The primary quantitative measure will be a composite Brain MRI-derived Responsiveness Index, computed from predefined brain MRI features. Structural and functional metrics will be combined into a single composite index using a prespecified analytic model. The composite index will be reported as a unitless continuous score, with higher values corresponding to imaging patterns associated with greater likelihood of LIFUP responsiveness.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P002816
  • 1K23NS140495 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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