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

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help patients with prolonged disorders of consciousness (pDOC), which can happen after severe brain injuries. The trial aims to see if pairing a type of nerve stimulation called transauricular vagus nerve stimulation (taVNS) with robotic tilt table mobilization (RTTM) can improve recovery for these patients. Currently, there aren’t many reliable treatments for pDOC, and this study hopes to find out if this combination can enhance patient outcomes safely and effectively.

To join the trial, participants must have been in a state of altered consciousness for more than three months due to a brain injury and be medically cleared to take part in physical therapy. The study will recruit 15 individuals who will undergo a 12-week rehabilitation program, which includes observing their usual care, participating in the new treatment, and then following up on their progress over time. It’s important to know that certain individuals, such as those who are medically unsafe for physical therapy or do not have a caregiver to help with consent, will not be eligible for the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with a diagnosis of pDOC (includes coma, VS/UWS, MCS, MCS +, MCS-) as defined as disorder of consciousness (DOC) greater than 3 months 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 3 months 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