Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Conscio… (NCT04065386) | Clinical Trial Compass
CompletedNot Applicable
Transcutaneous Auricular Vagal Nerve Stimulation for Post-coma Patients With Disorders of Consciousness
Belgium44 participantsStarted 2022-02-09
Plain-language summary
Non-invasive brain stimulations techniques have recently shown promising results in patients with disorders of consciousness. Notably, a case reported improvement of level of consciousness using transcutaneous auricular vagal nerve stimulation in a patient in unresponsive wakefulness syndrome.
Here we aim to assess the effects of transcutaneous auricular vagal nerve stimulation on post-coma patients with disorders of consciousness in a first randomized controlled trial. To measure these effects, behavioral (Coma recovery scale revised - CRS-R -primary outcome) and neuro-electrophysiological (electroencephalography - EEG - secondary outcome) data will be recorded in severely brain-injured patients with DOC.
Who can participate
Age range
18 Years – 99 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 ≥ 18 years old
* State of consciousness: unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) as defined by CRS-R performed during the screening period.
* Cerebral damage of known etiology
* Time since injury between 7 and 90 days
* Intact skin at the ears
* Consent given by the substitute decision maker
Exclusion Criteria:
* Anyone who is deemed medically unsuitable for this study as determined by a physician involved with the study (e.g. severe rythmic heart condition)
* Previous history of neurological disorders
* Documented pregnancy
* Active implant (i.e. pacemaker)
* Profound sedation such as one caused by general anaesthetics (e.g., propofol) or a combination of central acting sedatives (e.g., benzodiazepines, opioids)
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 used a non-invasive ear-based nerve stimulation technique called transcutaneous auricular vagal nerve stimulation for patients in vegetative or minimally conscious states — can you explain how this approach works and whether it might be relevant to my loved one's specific diagnosis?
2The trial measured changes in something called the CRS-R score, which I understand assesses levels of consciousness — what would a meaningful improvement on that scale actually look like in day-to-day terms for someone in my family member's condition?
3Since this trial is now completed, has the results data been published, and if so, what did it show about whether the stimulation actually changed patients' levels of consciousness compared to no treatment?
4This study was classified as 'Phase NA,' which I think means it's more of an exploratory study — does that mean there's still a lot unknown about the safety and effectiveness of this technique, and should we be cautious about it?
5Are there standard-of-care treatments or rehabilitation approaches that are already proven to support recovery from disorders of consciousness that we should consider before or alongside exploring a technique like this one?
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.
What they're measuring
1
Change in CRS-R total score and index score
Timeframe: Before the installation of the EEG equipment in the pre-stimulation period and 5 minutes after the post-stimulation resting state EEG (immediately after removing the equipment).