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NCT06939348 · ClinicalTrials.gov registry record · NA

Ultrasound Stimulation for Patients in a Disorder of Consciousness

A NA study of Consciousness Disorders and Disorders of Consciousness Due to Severe Brain Injury, sponsored by University of California, Los Angeles.

Recruiting
Registry status
NA
Development phase
60
Enrollment target
4
Study locations

NCT06939348: Recruiting NA study of Consciousness Disorders and Disorders of Consciousness Due to Severe Brain Injury, sponsored by University of California, Los Angeles.

NCT06939348 is a NA study of Consciousness Disorders and Disorders of Consciousness Due to Severe Brain Injury that is actively recruiting participants, run by University of California, Los Angeles. The registered enrollment target is 60 participants, above the 48-participant average among 4 other Consciousness Disorders trials with a reported enrollment target (25% higher). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06939348, a NA study of Consciousness Disorders and Disorders of Consciousness Due to Severe Brain Injury, is actively recruiting participants, sponsored by University of California, Los Angeles.

RECRUITING
Registry status
NA
Development phase
60 participants
Enrollment target
4
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 multicenter project aims to (1) establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment, (2) establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients and (3) explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication.

Primary Outcome

Outcome measures collected prior to tFUS/sham sessions will be compared to outcome measures obtained one week after tFUS/sham sessions. The two endpoint measures used will be one DoC-specific measure: the Coma Recovery Scale Revised (CRS-R). The Coma Recovery Scale Revised (CRS-R) ranges from 0 to 23 points, with higher scores indicating better neurological function and level of consciousness. A score of 0 represents the lowest level of neurological functioning, while a score of 23 represents th

Interventions

  • DEVICE The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain.

Study Locations (4)

California

  • The Regents of the University of California, Los Angeles - Los Angeles
  • Casa Colina Hospital and Centers for Healthcare - Pomona

Massachusetts

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

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-04-26
Est. Completion 2028-09-29
Phase NA

What NCT06939348 shows while recruiting

NCT06939348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 48-participant average among 4 other Consciousness Disorders trials with a reported enrollment target (25% higher).

The record links to 2 conditions, with Consciousness Disorders appearing as the primary indexed condition, and to 1 intervention - of which The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain. is the first listed.

NCT06939348 reports a single indexed study location in California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06939348 about?

NCT06939348 is a clinical study titled "Ultrasound Stimulation for Patients in a Disorder of Consciousness". 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 multicenter project aims to (1) establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with p...

What is the current status of trial NCT06939348?

This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-04-26. Estimated completion is 2028-09-29.

What conditions does trial NCT06939348 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 NCT06939348?

The interventions under investigation include: The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain. (DEVICE).

Who is sponsoring clinical trial NCT06939348?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06939348 being conducted?

This trial has 4 study locations across California, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT06939348, the US trial registry maintained by the National Library of Medicine. NCT06939348 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.