RecruitingNot ApplicableNCT06930716

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


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

15 participants

Start Date

Aug 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Physical therapy using Hocoma, a behavioral approach called Standard of Care, and others for people with altered level of consciousness, brain injury, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 22 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscutaneous vagus nerve stimulation (taVNS)

A non-invasive nerve stimulator that stimulates the vagus nerve through the ear.

DEVICEPhysical therapy using Hocoma

Progressive verticalization and mobilization using a robotic tilt table with robotic stepping (Erigo, Hocoma)

BEHAVIORALStandard of Care

Standard of care with no study interventions. This will include observation of whatever rehabilitation or medical care the patient is currently receiving.


Locations(1)

Abilities Research Center, Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT06930716


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