Recruiting

LIFUP

Sponsor:

Massachusetts General Hospital

Code:

NCT07277309

Conditions

Consciousness Disorders

Disorders of Consciousness Due to Severe Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Low-intensity focused ultrasound

Study Details

Brief 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.

Conditions

Consciousness Disorders

Disorders of Consciousness Due to Severe Brain Injury

Study ID

NCT07277309

Start date

May 26, 2026

Status verified date

Jun, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Michael Young, MD, MPhil

410-808-1196michael.young@mgh.harvard.edu

Jason Lew, DO

617-724-9247jlew3@mgb.org

Locations

Massachusetts General Hospital (The General Hospital Corp.)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Young, MD, MPhil

410-808-1196michael.young@mgh.harvard.edu

Principal Investigator:

Michael Young, MD, MPhil

Spaulding Rehabilitation Hospital Corporation, Inc.

Recruiting

Cambridge, Massachusetts, United States, 02138

Contacts

Jason Lew, DO

617-724-9247jlew3@mgb.org

Principal Investigator:

Jason Lew, DO

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Disorder of Consciousness
  • Vegetative State
  • Minimally Conscious State
  • Minimally Conscious State Plus
  • Minimally Conscious State Minus
  • Traumatic Brain Injury
  • CVA (Cerebrovascular Accident)
  • Anoxia, Brain
  • Thalamic Infarction
  • Coma; Prolonged

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-06-15.