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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06930716
Status
Recruiting
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Conditions

  • Altered Level of Consciousness
  • Brain Injury
  • Consciousness Disorders

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 12, 2025
Status verified
Apr 2025
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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,

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abilities Research Center, Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Jenna Tosto Mancuso
212-241-8454
Jenna Tosto-Mancuso (PRINCIPAL_INVESTIGATOR)

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By research site
Abilities Research Center, Icahn School of Medicine at Mount Sinai· New York, NY

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