Back to search results

Vagus Nerve Stimulation and Physical Therapy for Prolonged Disorders of Consciousness

This study is looking at whether combining two treatments can help people with prolonged disorders of consciousness (pDOC), which means being in a coma, vegetative state, or minimally conscious state for a long time. The treatments are transcutaneous vagus nerve stimulation (taVNS), a non-invasive device that stimulates a nerve through the ear, and physical therapy using a robotic tilt table (Erigo, Hocoma) for movement. The study aims to see if these combined interventions improve a person's level of consciousness and overall recovery. You may be able to join if you are 22 or older, have a pDOC lasting over 6 weeks, and are medically safe for physical therapy. Success will be measured by changes in consciousness and recovery scales. The current recruitment status is unclear, and the study plans to enroll 15 participants.

Study design
This interventional study plans to enroll 15 participants. It involves different phases of observation and intervention, but it is not specified if it is randomized or blinded.
What's involved
You would first have a 4-week observation period, followed by 4 weeks of physical therapy, then 4 weeks of combined taVNS and physical therapy. Assessments will be done at baseline, after each 4-week period, and then at 3, 6, and 12 months post-intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the intervention period, with assessments at 3, 6, and 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06930716

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

Recruiting
NAAges 22+InterventionalTreatment
Icahn School of Medicine at Mount Sinai
~15 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Transcutaneous vagus nerve stimulation (taVNS)Physical therapy using HocomaStandard of Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Coma Recovery Scale-Revised (CRS-R)
Measured over Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
+2 more outcomes measured

Conditions

Consciousness Disorders
Brain Injury
Altered Level of Consciousness

Explore related trials

Brain InjuryConsciousness Disorders

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jenna Tosto-Mancuso · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Jenna Tosto-Mancuso, PT, DPT, NCS
[email protected]
212-241-8454
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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 6 weeks 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 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

What this trial measures

  • Coma Recovery Scale-Revised (CRS-R)Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)

    The CRS-R is a standardized neurobehavioral rating scale used to monitor recovery of consciousness in persons with severe traumatic brain injury. Six subscales on the CRS-R are summed to provide the total score: auditory function (0-4), visual function (0-5), motor function (0-6), promotor/verbal function (0-3), communication (0-2) and arousal (0-3). Total scores on the CRS-R range from 0 to 23 with high scores generally indicating greater recovery

  • Glasgow Coma Scale (GCS)Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)

    The Glasgow Coma Scale (GCS) is a reliable and objective way of recording the initial and subsequent level of consciousness in a person after a brain injury. The range of total GCS score is 3 to15 where a higher GCS score represents a better outcome. The scores of subscales are summed to determine the total score\*. A GCS score of 13-15 is considered Mild impairment of consciousness; a GCS score of 9-12 is considered Moderate impairment of consciousness; and a GCS score of 3-8 is considered Severe. \*Subscales: * Eyes Response: Spontaneous=4; To sound=3; To Pressure=2; None=1; Not tested * Verbal Response: Oriented=5; Confused=4; Words=3; Sounds=2; None=1; Not tested * Motor Response: Obeys Commands=6; Localizes=5; Normal Flexion=4; Abnormal Flexion=3; Extension=2; None=1; Not tested

  • Glasgow Outcomes Scale- Extended (GOSE)Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)

    The GOSE is a scale for functional outcome following a severe traumatic injury. The GOSE is an ordinal variable with the following categories: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery. The GOSE score is determined by a structured interview with questions surrounding consciousness, independence inside and outside the home, social and leisure activities and return to normal life among others. The scale is 1-8, level 1 minimum score, level 8 maximum score. A higher score is considered to be a better result. A lower score indicates a worse result.