Consciousness DisordersNCT06930716
Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
A study testing Transcutaneous vagus nerve stimulation (taVNS) and Physical therapy using Hocoma in people with Consciousness Disorders and Brain Injury, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Consciousness Disorders, Brain Injury, Altered Level of Consciousness
- What is being tested?
- Transcutaneous vagus nerve stimulation (taVNS) and Physical therapy using Hocoma
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2025to 30 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abilities Research Center, Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Jenna Tosto Mancuso, 212-241-8454
Jenna Tosto-Mancuso
About this study
Official title: Use of Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness: A Pilot Feasibility Study
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.
Read the 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.
- Being tested
- Transcutaneous vagus nerve stimulation (taVNS), Physical therapy using Hocoma, Standard of Care
- Keywords
- Therapy, Rehabilitation, Neuromodulation
- Medical subject headings
- Consciousness Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagus nerve stimulation (taVNS)Device
A non-invasive nerve stimulator that stimulates the vagus nerve through the ear.
Physical therapy using HocomaDevice
Progressive verticalization and mobilization using a robotic tilt table with robotic stepping (Erigo, Hocoma)
Standard of CareBehavioural
Standard of care with no study interventions. This will include observation of whatever rehabilitation or medical care the patient is currently receiving.
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Device: Transcutaneous vagus nerve stimulation (taVNS); Device: Physical therapy using Hocoma; Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
Secondary outcomes (4)
Readmission Rates
Readmission Rates
Measured: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
Nociceptive Coma Scale- Revised (NCS-R)
The NCS-R evaluates behavioral responses to painful stimuli through three subscales: motor, verbal, and facial responses. Each subscale is scored from 0 (no response) to 3 (highest response level), with a total score ranging from 0 to 9, where higher scores indicate greater pain awareness.
Measured: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
Number of Physicians Follow-Up Visits
Number of Physicians Follow-Up Visits
Measured: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
Number of Emergency Room Visits
Number of Emergency Room Visits
Measured: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start12 Aug 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisordersStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Mancuso, Icahn School of Medicine at Mount Sinai
- Investigators
- Jenna Tosto-Mancuso, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06930716
- Sponsor's protocol ID
- STUDY-24-01339
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.