Ultrasound Stimulation for Patients in a Disorder of Consciousness (NCT06939348) | Clinical Trial Compass
RecruitingNot Applicable
Ultrasound Stimulation for Patients in a Disorder of Consciousness
United States60 participantsStarted 2025-04-26
Plain-language 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.
Who can participate
Age range18 Years – 79 Years
SexALL
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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.
What they're measuring
1
Establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment.
Timeframe: From Day 1 to 16
2
Establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients.
Timeframe: From Day 1 to 16
3
Explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication.