Recruiting

Vagus Nerve Stimulation

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06930716

Conditions

Consciousness Disorders

Brain Injury

Altered Level of Consciousness

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous vagus nerve stimulation (taVNS)

Physical therapy using Hocoma

Standard of Care

Study Details

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.

Conditions

Consciousness Disorders

Brain Injury

Altered Level of Consciousness

Study ID

NCT06930716

Start date

Aug 12, 2025

Status verified date

Mar, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients with Prolonged Disorders of Consciousness (pDOC)

Patients with pDOC receiving paired transauricular vagus nerve stimulation (taVNS) and robotic tilt table mobilization (RTTM) to maximize functional recovery,

Interventions

Transcutaneous vagus nerve stimulation (taVNS)

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

Physical therapy using Hocoma

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

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.

Primary outcome measure

  • Coma Recovery Scale-Revised (CRS-R) [ Time Frame: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3) ]
  • Glasgow Coma Scale (GCS) [ Time Frame: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3) ]
  • Glasgow Outcomes Scale- Extended (GOSE) [ Time Frame: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3) ]

Central Contacts and Locations

Central contacts

Jenna Tosto-Mancuso, PT, DPT, NCS

212-241-8454ARCClinic@mountsinai.org

Locations

Abilities Research Center, Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Jenna Tosto Mancuso

212-241-8454

Principal Investigator:

Jenna Tosto-Mancuso

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 18, 2026

Last verified

Mar, 2026

Keywords

  • Therapy
  • Rehabilitation
  • Neuromodulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-18.