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

NCT06930716 | Recruiting FDA Device

• 1 other identifier: STUDY-24-01339
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 present there are limited treatments that reliably lead to enhanced prognosis. The rehabilitation process throughout the continuum of care for patients with pDOC necessitates restorative strategies to facilitate arousal and functional recovery and coordinated medical management. Rehabilitation interventions for patients with DOC and pDOC have evolved in the past decade, with an emerging body of evidence highlighting the benefits of rehabilitation intervention even in the acute. While there is data to support the individual utility of these modalities, no work to date has investigated the benefits of pairing transauricular vagus nerve stimulation (taVNS) and robotic tilt table mobilization (RTTM) to maximize functional recovery in patients with pDOC. This study will report on the safety, feasibility, and preliminary short- and long-term outcomes of RTTM with simultaneously paired Transcutaneous auricular vagus nerve stimulation (taVNS) for Severe Acquired Brain Injury (SABI) patients with pDOC . Fifteen (15) participants will be recruited and complete a 12-week rehabilitation protocol using paired taVNS and RTTM. Once participants have been screened and enrolled in the study, they will complete three study phases: T1: a baseline observation of standard of care T2, intervention, and T3 longitudinal follow up.

Conditions

Consciousness Disorders; Brain Injury; Altered Level of Consciousness

Keywords

Therapy; Rehabilitation; Neuromodulation

Outcome Measures

Primary Outcomes (3)

• Coma Recovery Scale-Revised (CRS-R)

  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

  Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)

• Glasgow Coma Scale (GCS)

  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

  Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)

• Glasgow Outcomes Scale- Extended (GOSE)

  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.

  Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)

Secondary Outcomes (4)

• Readmission Rates

  Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)

• Nociceptive Coma Scale- Revised (NCS-R)

  Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)

• Number of Physicians Follow-Up Visits

  Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)

• Number of Emergency Room Visits

  Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)

Study Arms (1)

Patients with Prolonged Disorders of Consciousness (pDOC)

EXPERIMENTAL

Patients with pDOC receiving paired transauricular vagus nerve stimulation (taVNS) and robotic tilt table mobilization (RTTM) to maximize functional recovery,

Device: Transcutaneous vagus nerve stimulation (taVNS); Device: Physical therapy using Hocoma; Behavioral: Standard of Care

Interventions

Transcutaneous vagus nerve stimulation (taVNS) DEVICE

A non-invasive nerve stimulator that stimulates the vagus nerve through the ear.

Patients with Prolonged Disorders of Consciousness (pDOC)

Physical therapy using Hocoma DEVICE

Progressive verticalization and mobilization using a robotic tilt table with robotic stepping (Erigo, Hocoma)

Patients with Prolonged Disorders of Consciousness (pDOC)

Standard of Care BEHAVIORAL

Standard of care with no study interventions. This will include observation of whatever rehabilitation or medical care the patient is currently receiving.

Patients with Prolonged Disorders of Consciousness (pDOC)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Abilities Research Center, Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jenna Tosto-Mancuso

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Tosto-Mancuso, PT, DPT, NCS

CONTACT

212-241-8454; ARCClinic@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 16, 2025
• Study Start: August 12, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Proposals should be directed to AbilitiesResearchCenter@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (to be determined).

Locations

US (1)