Actively Recruiting
Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-09-19
15
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a diagnosis of prolonged disorder of consciousness (pDOC) lasting more than 3 months post onset
- Patients medically cleared as safe to participate in physical therapy by study physicians
You will not qualify if you...
- Patients who have emerged from minimally conscious state showing significant motor or communication function
- Patients medically unsafe for physical therapy, including those with intravenous sedation, skin breakdown, pressure injuries, or cardiovascular/cerebrovascular conditions preventing therapy
- Patients with disorders of consciousness less than 3 months post onset
- Patients who do not meet technical requirements for the robotic tilt table (weighing over 135 kg, leg length below 75 cm or above 100 cm, or fixed lower extremity contractures)
- Patients without a care partner or legally authorized representative to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Abilities Research Center, Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
J
Jenna Tosto-Mancuso, PT, DPT, NCS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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