Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post… (NCT01718249) | Clinical Trial Compass
CompletedNot Applicable
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness
France5 participantsStarted 2012-04
Plain-language summary
Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.
Who can participate
Age range
18 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:
* Patients stably in Vegetative state or Minimally conscious state, since at least 6 months after cerebrovascular accident and 1 year after traumatic brain injury.
Exclusion Criteria:
* Cerebral death, Locked-In Syndrome, blindness, deafness
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.
1This trial tested low-frequency deep brain stimulation in people with permanent vegetative state or minimally conscious state — given that it's now completed, has any data been published on whether CRS-R scores actually improved, and what might that mean for someone in my family member's situation?
2Deep brain stimulation is a surgical procedure that involves implanting electrodes in the brain — what are the specific risks of that kind of intervention for someone who is already in a fragile, post-coma state?
3Since this trial is listed as Phase NA, meaning it was likely a small exploratory study, how confident can we be in any results it produced, and would my doctor consider those results strong enough to inform treatment decisions?
4Are there non-surgical alternatives or other completed or ongoing studies that might be worth considering alongside or instead of an approach like this one?
5Given that this trial specifically focused on 'chronic and severe' disorders of consciousness, how would my doctor assess whether my family member's condition and timeline would have even matched what this study was looking at?
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.