Status:
RECRUITING
Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Consciousness Disorders
Brain Injury
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
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 p...
Detailed Description
T1: At baseline prior to initiating Phase 1, participants will be assessed using Coma Recovery Scale-Revised (CRS-R), Glasgow Coma Scale (GCS), and Glasgow Outcomes Scale- Extended (GOSE). Following t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06930716
Start Date
August 12 2025
End Date
December 30 2027
Last Update
September 19 2025
Active Locations (1)
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1
Abilities Research Center, Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029