Ultrasound Stimulation for Patients in a Disorder of Consciousness

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT06939348
Status
Recruiting
Apply to this trial

Conditions

  • Consciousness Disorders
  • Disorders of Consciousness Due to Severe Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 26, 2025
Status verified
May 2026
Primary completion
Mar 28, 2028
Completion
Sep 29, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
The Regents of the University of California, Los AngelesLos AngelesCalifornia90095
Martin Monti, PhD
[email protected]
310-825-8546
Martin Monti, PhD (PRINCIPAL_INVESTIGATOR)
Casa Colina Hospital and Centers for HealthcarePomonaCalifornia91767
Jeanette Gumarang, MSN
[email protected]
9095967733
Caroline Schnakers, PhD
[email protected]
9095967733
Caroline Schnakers, PhD (PRINCIPAL_INVESTIGATOR)
Massachusetts General Hospital (The General Hospital Corp.)BostonMassachusetts02114
Michael Young, MD
[email protected]
617-724-9247
Michael Young, MD (PRINCIPAL_INVESTIGATOR)
Spaulding Rehabilitation Hospital Corporation, Inc.CharlestownMassachusetts02129-3109
Jason Lew, DO
617-724-9247
Jason Lew, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
The Regents of the University of California, Los Angeles· Los Angeles, CACasa Colina Hospital and Centers for Healthcare· Pomona, CAMassachusetts General Hospital (The General Hospital Corp.)· Boston, MASpaulding Rehabilitation Hospital Corporation, Inc.· Charlestown, MA

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