BridgeMD
Tests treatment safety and results for Disorders of Consciousness Due to Severe Brain Injury
Official title Assessment of Safety and Feasibility of FUS Next Generation Dome Helmet (NGDH) to Perform Neuromodulation in Patients With Disorders of Consciousness
ClinicalTrials.gov ID: NCT07694258
What this study is testing
- What it's testing
- The main questions this study aims to answer are: Can low-intensity FUS neuromodulation be safely and feasibly administered to the bilateral central thalamus in patients with disorders of consciousness (DoC)? Does FUS neuromodulation result in short-term improvements in arousal or behavioral responsiveness?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Diagnosis of severe traumatic brain injury, hypoxic-ischemic brain injury, or other acute brain injury.
- Glasgow coma scale below 13 when off sedation, or on minimal sedation.
- Absence of another better explanation for the depressed level of consciousness (e.g,, metabolic abnormality, seizures)
- Intracranial pressure (ICP) is within a normal range (\< 20 cm H2O), or, a neurosurgeon associated with the study and/or the treating physician agree...
- The treating physician and/or neurosurgeon associated with the study evaluate it to be safe for the patient to be transported to the MRI scanner for...
You likely can't join if
- Active seizure activity or post-anoxic myoclonus at the time of proposed treatment
- Taking full anti-coagulation medication (does not include deep-vein-thrombosis chemoprophylaxis)
- Skull anatomy incompatible with safe FUS delivery (as determined by CT)
- Medical instability that would preclude safe transport or prolonged supine positioning
- Presence of any MRI-incompatible implants or devices
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.