Promoting Recovery After Brain Injury Using Focused Ultrasound
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorMassachusetts General Hospital
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 project aims to (1) determine neurobehavioral responses to low-intensity focused ultrasound (LIFUP) in patients with disorders of consciousness (DoC) following brain injury, (2) determine neurophysiologic (EEG) responses to LIFUP in patients with DoC and (3) identify and evaluate ethical perspectives of patient representatives (family members and surrogate decision-makers) surrounding investigation of therapeutic neuromodulation technologies such as LIFUP in patients with DoC.
Eligibility criteria
Qualifiers
Brain injury resulting in DoC diagnosis, following international guidelines
At least 18 years of age
Legally authorized representative (surrogate) available to consent
Disqualifiers
History of neurological disorder other than the brain injury
Metal implant or other condition precluding MRI
Manifest continuous spontaneous movement (which would prevent safe/successful MRI)
Participation in concurrent therapeutic study
Trial design
Treatments tested in this trial
- Low-intensity focused ultrasound
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov