RECRUITINGINTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Diagnosis of DoC, following international guidelines, as assessed with the CRS-R. 2. Prolonged status (\>28days post-injury) 3. 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. 4. legally authorized representative available to consent for the patient to participate in the study Who Should NOT Join This Trial: 1. History of neurological disorder (other than the brain injury). 2. Metal implant or other condition precluding safe entry in the MR-environment. 3. Manifest continuous spontaneous movement (which would prevent safe/successful imaging). 4. Participation in another concurrent clinical trial. 5. Need for mechanical ventilation. 6. Craniotomy (no bone flap). 7. Cranioplasty spanning the left temporal bone window. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Diagnosis of DoC, following international guidelines, as assessed with the CRS-R. 2. Prolonged status (\>28days post-injury) 3. 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. 4. legally authorized representative available to consent for the patient to participate in the study Exclusion Criteria: 1. History of neurological disorder (other than the brain injury). 2. Metal implant or other condition precluding safe entry in the MR-environment. 3. Manifest continuous spontaneous movement (which would prevent safe/successful imaging). 4. Participation in another concurrent clinical trial. 5. Need for mechanical ventilation. 6. Craniotomy (no bone flap). 7. Cranioplasty spanning the left temporal bone window.

Treatments Being Tested

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.

Locations (4)

The Regents of the University of California, Los Angeles

Los Angeles, California, United States

Casa Colina Hospital and Centers for Healthcare

Pomona, California, United States

Massachusetts General Hospital (The General Hospital Corp.)

Boston, Massachusetts, United States

Spaulding Rehabilitation Hospital Corporation, Inc.

Charlestown, Massachusetts, United States