NCT06930716

Paired Vagus Nerve Stimulation in Mobilization of 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

T1: At baseline prior to initiating Phase 1, participants will be assessed using Coma Recovery Scale-Revised (CRS-R), Glasgow Coma Scale (GCS), and Glasgow Outcomes Scale- Extended (GOSE). Following this baseline assessment, participants will continue with 4 weeks of their current standard of care. During Phase 1, no study interventions will be implemented. At completion of T1, the CRS-R, GCS, and GOSE will be reassessed. Following Phase 1, T2a: will be initiated immediately thereby and will entail a 4-week mobilization only phase. Participants will complete 8 sessions of physical therapy over 4 weeks, receiving progressive verticalization and mobilization using a robotic tilt table with robotic stepping (Erigo; Hocoma). T2b: Immediately after 4 week mobilization only period, participants will complete 8 sessions of physical therapy over 4 weeks, receiving the paired taVNS + RTTM intervention. Upon completion of phase 2b, participants will be reassessed with CRS-R, GCS, and GOSE. T3: Following the intervention period, participants will complete three additional study visits for assessment at 3-, 6-, and 12-months post intervention using the CRS-R, GOSE, and GCS. Across all study phases, secondary healthcare utilization, including re-admission rates, number of physicians follow up visits and emergency room visits, will be captured from the patient electronic medical record (EMR) and reported.

Conditions

• Consciousness Disorders
• Brain Injury
• Altered Level of Consciousness

Interventions

Type	Name	Description
DEVICE	Transcutaneous vagus nerve stimulation (taVNS)	A non-invasive nerve stimulator that stimulates the vagus nerve through the ear.
DEVICE	Physical therapy using Hocoma	Progressive verticalization and mobilization using a robotic tilt table with robotic stepping (Erigo, Hocoma)
BEHAVIORAL	Standard of Care	Standard of care with no study interventions. This will include observation of whatever rehabilitation or medical care the patient is currently receiving.

Timeline

• Start date: 2025-08-12
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2025-04-16
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study