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NCT07277309 · ClinicalTrials.gov registry record · NA

Promoting Recovery After Brain Injury Using Focused Ultrasound

A NA study of Consciousness Disorders and Disorders of Consciousness Due to Severe Brain Injury, sponsored by Massachusetts General Hospital.

Recruiting
Registry status
NA
Development phase
36
Enrollment target
2
Study locations

NCT07277309: Recruiting NA study of Consciousness Disorders and Disorders of Consciousness Due to Severe Brain Injury, sponsored by Massachusetts General Hospital.

NCT07277309 is a NA study of Consciousness Disorders and Disorders of Consciousness Due to Severe Brain Injury that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 36 participants, below the 54-participant average among 4 other Consciousness Disorders trials with a reported enrollment target (33% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07277309, a NA study of Consciousness Disorders and Disorders of Consciousness Due to Severe Brain Injury, is actively recruiting participants, sponsored by Massachusetts General Hospital.

RECRUITING
Registry status
NA
Development phase
36 participants
Enrollment target
2
Study locations

Study 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.

Primary Outcome

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 repre

Conditions Studied

Consciousness Disorders Disorders of Consciousness Due to Severe Brain Injury

Interventions

  • DEVICE Low-intensity focused ultrasound

Study Locations (2)

Massachusetts

  • Massachusetts General Hospital (The General Hospital Corp.) - Boston
  • Spaulding Rehabilitation Hospital Corporation, Inc. - Cambridge

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2026-03
Est. Completion 2029-07
Phase NA
Massachusetts General Hospital

2,032 total trials

What NCT07277309 shows while recruiting

NCT07277309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 54-participant average among 4 other Consciousness Disorders trials with a reported enrollment target (33% lower).

The record links to 2 conditions, with Consciousness Disorders appearing as the primary indexed condition, and to 1 intervention - of which Low-intensity focused ultrasound is the first listed.

NCT07277309 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT07277309 about?

NCT07277309 is a clinical study titled "Promoting Recovery After Brain Injury Using Focused Ultrasound". 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 disorder...

What is the current status of trial NCT07277309?

This trial is currently recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2026-03. Estimated completion is 2029-07.

What conditions does trial NCT07277309 study?

This clinical trial studies the following conditions: Consciousness Disorders, Disorders of Consciousness Due to Severe Brain Injury.

What interventions are being tested in trial NCT07277309?

The interventions under investigation include: Low-intensity focused ultrasound (DEVICE).

Who is sponsoring clinical trial NCT07277309?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07277309 being conducted?

This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT07277309

Source: ClinicalTrials.gov NCT07277309, the US trial registry maintained by the National Library of Medicine. NCT07277309 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.