Recruiting

tFUS

Sponsor:

UCLA

Code:

NCT06939348

Conditions

Consciousness Disorders

Disorders of Consciousness Due to Severe Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

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 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.

Conditions

Consciousness Disorders

Disorders of Consciousness Due to Severe Brain Injury

Study ID

NCT06939348

Start date

Apr 26, 2025

Status verified date

May, 2026

Completion date

Sep 29, 2028

Anticipated

Primary completion date

Mar 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of DoC, following international guidelines, as assessed with the CRS-R.
2. Prolonged status (>28days post-injury)
3. If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and the patient will be willing to remain on a stable regimen during the protocol.
4. legally authorized representative available to consent for the patient to participate in the study

Exclusion Criteria:

1. History of neurological disorder (other than the brain injury).
2. Metal implant or other condition precluding safe entry in the MR-environment.
3. Manifest continuous spontaneous movement (which would prevent safe/successful imaging).
4. Participation in another concurrent clinical trial.
5. Need for mechanical ventilation.
6. Craniotomy (no bone flap).
7. Cranioplasty spanning the left temporal bone window.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham-tFUS group

Sham-tFUS group will receive sham sonication in the first session and tFUS in the second session

active comparator: tFUS-tFUS group

tFUS-tFUS group will receive 2 sessions of tFUS

Interventions

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

The BX Pulsar 1002 consists of two main elements: the transducer and the ultrasound console. The transducer itself and the housing for it went through several iterations in order to be compatible with an MRI environment. Currently, the transducer and its housing are deemed MR-conditional at 3T with SAR ≤ 2W/kg. The design includes a solid acoustic coupling gel pad attached to the front of the transducer to provide good acoustic transmission into the scalp. An outer housing was designed to attach the transducer firmly to the head above the temporal window, and to allow it to be moved side to side to accurately target intended structures.

Primary outcome measure

  • Establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment. [ Time Frame: From Day 1 to 16 ]
  • Establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients. [ Time Frame: From Day 1 to 16 ]
  • Explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication. [ Time Frame: From Day 1 to 16 ]

Central Contacts and Locations

Central contacts

Martin M Monti, PhD

310-825-8546monti@psych.ucla.edu

Caroline Schnakers, PhD

(909) 596-7733cschnakers@casacolina.org

Locations

The Regents of the University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Martin Monti, PhD

310-825-8546monti@psych.ucla.edu

Principal Investigator:

Martin Monti, PhD

Casa Colina Hospital and Centers for Healthcare

Recruiting

Pomona, California, United States, 91767

Contacts

Jeanette Gumarang, MSN

9095967733jgumarang@casacolina.org

Caroline Schnakers, PhD

9095967733cschnakers@casacolina.org

Principal Investigator:

Caroline Schnakers, PhD

Massachusetts General Hospital (The General Hospital Corp.)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Young, MD

617-724-9247michael.young@mgh.harvard.edu

Principal Investigator:

Michael Young, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

May 22, 2026

Last verified

May, 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 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-05-22.