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Recruiting NCT07277309

Promoting Recovery After Brain Injury Using Focused Ultrasound

No phase Interventional Consciousness Disorders Disorders of Consciousness Due to Severe Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-intensity focused ultrasound.
Who it may be relevant to
Registry conditions: Consciousness Disorders, Disorders of Consciousness Due to Severe Brain Injury. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • Brain MRI-derived responsiveness index (structural-functional signature predicting LIFUP response) [Time frame: Day 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Massachusetts General Hospital (The General Hospital Corp.) — Boston
  • Spaulding Rehabilitation Hospital Corporation, Inc. — Cambridge

Identifiers

NCT: NCT07277309 · 2025P002816 · 1K23NS140495

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗