Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

4
The Regents of the University of California, Los Angeles90095, Los AngelesCalifornia, United States
Casa Colina Hospital and Centers for Healthcare91767, PomonaCalifornia, United States
Massachusetts General Hospital (The General Hospital Corp.)02114, BostonMassachusetts, United States
Spaulding Rehabilitation Hospital Corporation, Inc.02129-3109, CharlestownMassachusetts, United States

Sponsors and collaborators

University of California, Los Angeles

Lead sponsor

Casa Colina Hospital and Centers for Healthcare

Collaborator

Spaulding Rehabilitation Hospital

Collaborator

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov