Using Vagus Nerve Stimulation and Robotic Mobilization for Patients with Prolonged Disorders of Consciousness
Use of Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness: A Pilot Feasibility Study
This study is testing if combining a special nerve stimulation treatment with robotic help to move can improve the recovery of patients who have been in a prolonged state of unconsciousness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06930716 on ClinicalTrials.gov |
What this trial studies
This study investigates the combined effects of transauricular vagus nerve stimulation (taVNS) and robotic tilt table mobilization (RTTM) on patients with prolonged disorders of consciousness (pDOC). Participants will undergo a baseline assessment followed by a standard care phase, a mobilization-only phase, and then a phase combining both interventions. The study aims to evaluate safety and efficacy through various assessments over a 12-month period. Data on healthcare utilization will also be collected to understand the broader impact of the interventions.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with prolonged disorders of consciousness lasting more than 3 months post-injury.
Not a fit: Patients who have emerged from a minimally conscious state or those deemed medically unsafe for physical therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and functional outcomes for patients with prolonged disorders of consciousness.
How similar studies have performed: While individual modalities have shown promise, this specific combination of taVNS and RTTM has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a diagnosis of pDOC (includes coma, VS/UWS, MCS, MCS +, MCS-) as defined as disorder of consciousness (DOC) greater than 3 months 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 3 months 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
Where this trial is running
New York, New York
- Abilities Research Center, Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jenna Tosto-Mancuso — Icahn School of Medicine at Mount Sinai
- Study coordinator: Jenna Tosto-Mancuso, PT, DPT, NCS
- Email: ARCClinic@mountsinai.org
- Phone: 212-241-8454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.