NCT06939348Recruiting
Ultrasound Stimulation for Patients in a Disorder of Consciousness
Safety and Efficacy of Thalamic Focused Ultrasound Stimulation (tFUS) for Promoting Recovery After Severe Traumatic Brain Injury
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 7 Apr 2025
- Start date
- 26 Apr 2025
- Primary completion date
- 28 Mar 2028
- Lead sponsor
- University of California, Los Angeles
- Diseases
- Stroke
- NCT number
- NCT06939348
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 26 Apr 2025 to the primary completion date, 28 Mar 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another concurrent clinical trial.
Other illness
- History of neurological disorder (other than the brain injury).
- Metal implant or other condition precluding safe entry in the MR-environment.
Other
- Manifest continuous spontaneous movement (which would prevent safe/successful imaging).
- Need for mechanical ventilation.
- Craniotomy (no bone flap).
- Cranioplasty spanning the left temporal bone window.
Who the study is looking for
- 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
Age in the registry: 18 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital (The General Hospital Corp.) Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Spaulding Rehabilitation Hospital Corporation, Inc. Coordinator of this site? Confirm its status | Charlestown | United States | Not yet recruiting |
| The Regents of the University of California, Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Casa Colina Hospital and Centers for Healthcare Coordinator of this site? Confirm its status | Pomona | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.