Ultrasound Stimulation for Disorders of Consciousness
This study is testing a device called the Brainsonix BX Pulsar 1002, which uses low-intensity focused ultrasound pulsations (LIFUP) to stimulate the brain. The goal is to see if this treatment can help people recover from a prolonged disorder of consciousness (DoC) after a severe brain injury. Researchers want to find out if it's effective compared to a sham (inactive) treatment, and if different doses are safe and work well. They are also looking for signs in the brain that might predict who will respond best. This study is currently recruiting 60 participants aged 18 to 79 who have been in a DoC for more than 28 days.
- Study design
- This is an interventional study with 60 planned participants, using a randomized, double-blind, sham-controlled design. Participants will be divided into groups, with some receiving the active treatment and others a sham treatment.
- What's involved
- Participants will receive either two sessions of active ultrasound treatment or one sham session followed by one active session. Outcome measures will be collected before and one week after these sessions.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary and secondary outcomes are measured from Day 1 to Day 16, indicating a short-term follow-up period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Ultrasound Stimulation for Patients in a Disorder of Consciousness
At a glance
Conditions
NCT06939348
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Casa Colina Hospital and Centers for Healthcare
Pomona, Californiastudy coordinator listed
Recruiting
Massachusetts General Hospital (The General Hospital Corp.)
Boston, Massachusettsstudy coordinator listed
Recruiting
Spaulding Rehabilitation Hospital Corporation, Inc.
Charlestown, Massachusettsstudy coordinator listed
Not yet recruiting
The Regents of the University of California, Los Angeles
Los Angeles, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Martin M Monti, PhD · PRINCIPAL_INVESTIGATOR · University of California, Los Angeles
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment.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.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.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.