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Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness

NCT06930716 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-09-19

No results posted yet for this study

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.

Conditions

  • Consciousness Disorders
  • Brain Injury
  • Altered Level of Consciousness

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Jenna Tosto-Mancuso · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2027-12-30
Completion
2027-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06930716 on ClinicalTrials.gov