NCT06930716 Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
| NCT ID | NCT06930716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Consciousness Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-08-12 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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 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
Contact & Investigator
Jenna Tosto-Mancuso
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06930716 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Consciousness Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06930716 currently recruiting?
Yes, NCT06930716 is actively recruiting participants. Contact the research team at ARCClinic@mountsinai.org for enrollment information.
Where is the NCT06930716 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06930716 clinical trial?
NCT06930716 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Jenna Tosto-Mancuso at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 15 participants.