Clinical trial NCT06930716: Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
Official title: Use of Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Consciousness Disorders
Brain Injury
Altered Level of Consciousness
Keywords: Therapy
Rehabilitation
Neuromodulation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 15
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Coma Recovery Scale-Revised (CRS-R)
timeFrame: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
measure: Glasgow Coma Scale (GCS)
timeFrame: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
measure: Glasgow Outcomes Scale- Extended (GOSE)
timeFrame: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
Secondary outcomes:
measure: Readmission Rates
timeFrame: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
measure: Nociceptive Coma Scale- Revised (NCS-R)
timeFrame: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
measure: Number of Physicians Follow-Up Visits
timeFrame: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
measure: Number of Emergency Room Visits
timeFrame: Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)
Other outcomes:
Locations:
city: New York
country: United States
facility: Abilities Research Center, Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jenna Tosto-Mancuso
role: PRINCIPAL_INVESTIGATOR
References: