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

RecruitingNAAges 22 Years - anyAllIcahn School of Medicine at Mount Sinai
NCT06930716 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 (RT

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📋 Eligibility rules (as published)
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
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What it tests

  • Transcutaneous vagus nerve stimulation (taVNS)
  • Physical therapy using Hocoma
  • Standard of Care
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Where

1 site
Abilities Research Center, Icahn School of Medicine at Mount Sinai
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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