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 |
Trial Parameters
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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 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 * weig