Using Vagus Nerve Stimulation and Robotic Mobilization for Patients with Prolonged Disorders of Consciousness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the combined effects of transauricular vagus nerve stimulation (taVNS) and robotic tilt table mobilization (RTTM) on patients with prolonged disorders of consciousness (pDOC). Participants will undergo a baseline assessment followed by a standard care phase, a mobilization-only phase, and then a phase combining both interventions. The study aims to evaluate safety and efficacy through various assessments over a 12-month period. Data on healthcare utilization will also be collected to understand the broader impact of the interventions.

Why it matters

Who can join: the full rules

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

Where it's running

• Abilities Research Center, Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jenna Tosto-Mancuso — Icahn School of Medicine at Mount Sinai
• Study coordinator: Jenna Tosto-Mancuso, PT, DPT, NCS
• Email: ARCClinic@mountsinai.org
• Phone: 212-241-8454

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Exploration of whole-brain radiotherapy with PD-1 inhibitors for brain injury in SCLC

  This study tests whether adding PD-1 inhibitors to chemotherapy and prophylactic brain irradiation helps some small cell lung cancer patients protect the brain.

  Recruiting Guizhou Medical University · Guiyang, Guizhou · NCT07905937

• Informational Needs of Caregivers of Patients in Neuro Rehab: Validating the QBI-R/V

  This study tests a caregiver questionnaire (QBI-R and QBI-V) to see how well it measures caregivers’ informational needs during neuromotor rehabilitation.

  Recruiting at 13 sites Istituti Clinici Scientifici Maugeri SpA · Sciacca, Agrigento and 12 other locations · NCT07903298

• Can a bedside brain scan (fNIRS) detect activity in healthy people and in people with disorders of consciousness

  This observational study tests whether functional near-infrared spectroscopy (fNIRS) can measure brain activity at the bedside in healthy adults and in patients with disorders of consciousness in the Neuro-ICU.

  Recruiting University of California, Los Angeles · Los Angeles, California · NCT07485361

• The Coma Family Program: a resilience program for caregivers of patients with severe brain injury

  This program tests whether the Coma Family Program can better reduce emotional distress in caregivers of patients with severe acute brain injury compared to a health education control.

  Recruiting at 3 sites Icahn School of Medicine at Mount Sinai · Baltimore, Maryland and 3 other locations · NCT07331324

• Focused ultrasound to promote recovery after severe brain injury.

  This test uses low-intensity focused ultrasound on adults with disorders of consciousness after severe brain injury to see if it improves responsiveness and brain activity.

  Recruiting at 2 sites Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT07277309

• Program to restore resilience and reduce PTSD after military sexual trauma or intimate partner violence with brain injury

  This trial tests whether adding a web-based emotion regulation program to exposure therapy helps female Veterans with military sexual trauma or intimate partner violence and a history of brain injury reduce PTSD symptoms.

  Recruiting Icahn School of Medicine at Mount Sinai · Houston, Texas · NCT06988787

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.