Low-Intensity Focused Ultrasound on Individuals With Disorder of Consciousness of Traumatic Brain… (NCT04306601) | Clinical Trial Compass
CompletedNot Applicable
Low-Intensity Focused Ultrasound on Individuals With Disorder of Consciousness of Traumatic Brain Injury
South Korea10 participantsStarted 2020-06-25
Plain-language summary
Low-intensity focused ultrasound can be effective in severe TBI patients with disorder of consciousness. This study is a prospective single arm, open-label and explorative clinical trial to evaluate the therapeutic effect of recovery from DoC and safety of low-intensity focused ultrasound stimulation at thalamic area in patients with post-traumatic DoC.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age is 19 years or higher
. The patient was diagnosed with traumatic brain injury
. A patient 6 months after brain damage
. A patient was diagnosed with unwakefulness syndrome or minimally conscious state
Exclusion criteria
. The patient needs changes of drugs that can affect changes in consciousness during the study's participation.
. Cardiopulmonary resuscitation was performed on the patient for more than 10 minutes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. The patient has severe thalamic atrophy of both sides, and it is impossible to determine the target area to be stimulated by sonication
. The patient has severe medical conditions which can affect the consciousness
. In brain computed tomography, calcification or foreign object (metallic materials, shunt catheter, etc.) that affects sonication are found in brain or skull.
. In brain MRI, an abnormal brain blood flow or blood vessel is found