Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness (NCT06930716) | Clinical Trial Compass
RecruitingNot Applicable
Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
United States15 participantsStarted 2025-08-12
Plain-language summary
Prolonged disorders of consciousness (pDOC) are defined as DOC lasting \>1 year post injury for patients with Traumatic Brain Injury (TBI) and \>3 months post injury for patients with non-TBI and at present there are limited treatments that reliably lead to enhanced prognosis. The rehabilitation process throughout the continuum of care for patients with pDOC necessitates restorative strategies to facilitate arousal and functional recovery and coordinated medical management. Rehabilitation interventions for patients with DOC and pDOC have evolved in the past decade, with an emerging body of evidence highlighting the benefits of rehabilitation intervention even in the acute. While there is data to support the individual utility of these modalities, no work to date has investigated the benefits of pairing transauricular vagus nerve stimulation (taVNS) and robotic tilt table mobilization (RTTM) to maximize functional recovery in patients with pDOC. This study will report on the safety, feasibility, and preliminary short- and long-term outcomes of RTTM with simultaneously paired Transcutaneous auricular vagus nerve stimulation (taVNS) for Severe Acquired Brain Injury (SABI) patients with pDOC . Fifteen (15) participants will be recruited and complete a 12-week rehabilitation protocol using paired taVNS and RTTM. Once participants have been screened and enrolled in the study, they will complete three study phases: T1: a baseline observation of standard of care T2, intervention, and T3 longitudinal follow up.
Who can participate
Age range
22 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 with a diagnosis of pDOC (includes coma, VS/UWS, MCS, MCS +, MCS-) as defined as disorder of consciousness (DOC) greater than 6 weeks post onset
* Patients deemed medically safe to participate in physical therapy (PT) as evaluated by the study physicians.
Exclusion Criteria:
* Patients who have emerged from MCS (CRS-R score 6 on Motor Function scale and/or 2 on Communication Scale).
* Patients medically unsafe for participation in PT as indicated by one of the study physicians (including but not limited to those receiving intravenous sedation, those with integumentary breakdown or known pressure injuries, those with cardiovascular or cerebrovascular conditions precluding initiation of physical therapy \[ie uncontrolled intracranial pressure, severe symptomatic orthostatic hypotension, etc.).
* Patients with DOC less than 6 weeks post onset will also be excluded.
* Patients who do not meet technical requirements of the RTTM device will be excluded
* weighing greater than 135 kg
* length of legs below 75 cm or above 100 cm,
* fixed contractures of lower extremity including hip, knee, ankle, or foot).
* Does not have an identified care partner or legally authorized representative to consent to participation
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 uses vagus nerve stimulation paired with mobilization for prolonged disorders of consciousness — can you explain what 'paired' means here, and whether my loved one's specific type of brain injury and level of consciousness would make them a reasonable candidate to discuss for this kind of approach?
2Since this trial is listed as Phase NA, it seems like it may be an early or exploratory study — what does that mean for how much is already known about the safety and benefit of pairing vagus nerve stimulation with mobilization in patients with disorders of consciousness?
3The trial is measuring outcomes using the Coma Recovery Scale-Revised, Glasgow Coma Scale, and Glasgow Outcomes Scale-Extended — can you help me understand what a meaningful improvement on those scales would actually look like day-to-day for someone in a prolonged disorder of consciousness?
4Are there standard rehabilitation or stimulation approaches already in use for prolonged disorders of consciousness that we should consider first, or alongside thinking about this trial, before committing to an experimental protocol?
5What would participating in this trial actually involve logistically — how often would the stimulation and mobilization sessions happen, where would they take place, and how demanding would that schedule be for the patient and our family?
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
Coma Recovery Scale-Revised (CRS-R)
Timeframe: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
2
Glasgow Coma Scale (GCS)
Timeframe: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
3
Glasgow Outcomes Scale- Extended (GOSE)
Timeframe: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)