NCT06939348 · University of California, Los Angeles
Ultrasound Stimulation for Patients in a Disorder of Consciousness
(tFUS)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
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 measures
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
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 the highest level of neurological functioning.
Establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients.
Time frame: From Day 1 to 16
Safety. Proportion of (severe) adverse events (primary measure) will be documented using the Adverse Event Questionnaire (AEQ, also used in NCT04921683) and the Vital signs CRF (F0026),22 within one week of intervention/sham, in the tFUS-tFUS group and in the Sham-tFUS group
Explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication.
Time frame: From Day 1 to 16
using the EEG recordings, power spectral density will be calculated within predefined frequency band and ABCD level classification (that reflects the degree of thalamocortical disconnection; primary measure) will be applied based on spectral peaks in these frequencies. This measure is calculated in percentage (%) of total power density.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of DoC, following international guidelines, as assessed with the CRS-R.
- Prolonged status (\>28days post-injury)
- 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.
- legally authorized representative available to consent for the patient to participate in the study
Exclusion criteria
- History of neurological disorder (other than the brain injury).
- Metal implant or other condition precluding safe entry in the MR-environment.
- Manifest continuous spontaneous movement (which would prevent safe/successful imaging).
- Participation in another concurrent clinical trial.
- Need for mechanical ventilation.
- Craniotomy (no bone flap).
- Cranioplasty spanning the left temporal bone window.
Where
- Los Angeles, California
- Pomona, California
- Boston, Massachusetts
- Charlestown, Massachusetts
Collaborators
Casa Colina Hospital and Centers for Healthcare, Spaulding Rehabilitation Hospital, Massachusetts General Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations