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

NCT ID: NCT06930716

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-12
• Study Completion Date: 2027-12-30

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.

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 this baseline assessment, participants will continue with 4 weeks of their current standard of care. During Phase 1, no study interventions will be implemented. At completion of T1, the CRS-R, GCS, and GOSE will be reassessed. Following Phase 1,

T2a: will be initiated immediately thereby and will entail a 4-week mobilization only phase. Participants will complete 8 sessions of physical therapy over 4 weeks, receiving progressive verticalization and mobilization using a robotic tilt table with robotic stepping (Erigo; Hocoma).

T2b: Immediately after 4 week mobilization only period, participants will complete 8 sessions of physical therapy over 4 weeks, receiving the paired taVNS + RTTM intervention. Upon completion of phase 2b, participants will be reassessed with CRS-R, GCS, and GOSE.

T3: Following the intervention period, participants will complete three additional study visits for assessment at 3-, 6-, and 12-months post intervention using the CRS-R, GOSE, and GCS. Across all study phases, secondary healthcare utilization, including re-admission rates, number of physicians follow up visits and emergency room visits, will be captured from the patient electronic medical record (EMR) and reported.

Conditions

Consciousness Disorders; Brain Injury; Altered Level of Consciousness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with Prolonged Disorders of Consciousness (pDOC)

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

Group Type: EXPERIMENTAL

Transcutaneous vagus nerve stimulation (taVNS)

Intervention Type: DEVICE

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

Physical therapy using Hocoma

Intervention Type: DEVICE

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

Standard of Care

Intervention Type: BEHAVIORAL

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

Interventions

Transcutaneous vagus nerve stimulation (taVNS)

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

Intervention Type: DEVICE

Physical therapy using Hocoma

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

Intervention Type: DEVICE

Standard of Care

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Jenna Mancuso

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenna Tosto-Mancuso

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Abilities Research Center, Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jenna Tosto-Mancuso, PT, DPT, NCS

Role: CONTACT

ARCClinic@mountsinai.org

212-241-8454

Facility Contacts

Jenna Tosto Mancuso

Role: primary

212-241-8454

Other Identifiers

STUDY-24-01339

Identifier Type: -

Identifier Source: org_study_id