Actively Recruiting
Use of Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness: A Pilot Feasibility Study
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-09-19
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to investigate the safety, feasibility, and preliminary outcomes of combining transauricular vagus nerve stimulation (taVNS) with robotic tilt table mobilization (RTTM) in patients with prolonged disorders of consciousness (pDOC) following severe acquired brain injury. These disorders last more than one year after traumatic brain injury or more than three months after non-traumatic brain injury, and current treatments rarely improve prognosis. Rehabilitation strategies are essential to support arousal and recovery in these patients, and this study explores the potential benefits of pairing two emerging therapies. Participants will undergo a 12-week rehabilitation protocol divided into three phases. The first phase (T1) involves four weeks of standard care without study interventions, followed by a four-week period (T2a) of robotic tilt table mobilization with progressive verticalization and stepping exercises. The next four weeks (T2b) combine the robotic mobilization with transcutaneous auricular vagus nerve stimulation. After completing these phases, participants will enter a follow-up period (T3) with assessments at 3, 6, and 12 months post-intervention. Throughout the study, participants will be evaluated using scales measuring consciousness and recovery, including the Coma Recovery Scale-Revised (CRS-R), Glasgow Coma Scale (GCS), and Glasgow Outcomes Scale-Extended (GOSE). Additional outcomes such as healthcare utilization, readmission rates, and emergency visits will also be tracked from medical records. These assessments will occur at baseline, during the intervention phases, and throughout the year-long follow-up to monitor short- and long-term effects.
CONDITIONS
Brief 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 diagnosed with prolonged disorders of consciousness (pDOC) lasting more than 3 months post onset
- Patients medically cleared to participate in physical therapy by study physicians
You will not qualify if you...
- Patients who have emerged from minimally conscious state (CRS-R score 6 on Motor Function scale or 2 on Communication Scale)
- Medically unsafe to participate in physical therapy (e.g., intravenous sedation, skin breakdown, cardiovascular or cerebrovascular conditions preventing therapy)
- Disorder of consciousness less than 3 months post onset
- Do not meet technical requirements for robotic tilt table mobilization (weighing over 135 kg, leg length below 75 cm or above 100 cm, fixed contractures of lower extremities)
- Lack a care partner or legally authorized representative to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 4 weeks
Participants continue with their current standard of care without study interventions.
Assessments at the start and end of this period
Duration - 4 weeks
Participants receive physical therapy involving progressive verticalization and mobilization using a robotic tilt table with robotic stepping.
8 physical therapy sessions over 4 weeks
Duration - 4 weeks
Participants receive paired transcutaneous vagus nerve stimulation combined with robotic tilt table mobilization physical therapy.
8 physical therapy sessions over 4 weeks with nerve stimulation
Duration - 12 months
Participants are reassessed at multiple time points after intervention to monitor recovery and health status.
3 visits at 3, 6, and 12 months post intervention
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
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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