Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Transcutaneous vagus nerve stimulation (taVNS)
DeviceA non-invasive nerve stimulator that stimulates the vagus nerve through the ear.
Physical therapy using Hocoma
DeviceProgressive verticalization and mobilization using a robotic tilt table with robotic stepping (Erigo, Hocoma)
Standard of Care
BehavioralStandard of care with no study interventions. This will include observation of whatever rehabilitation or medical care the patient is currently receiving.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Patients with Prolonged Disorders of Consciousness (pDOC)Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)2
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
Time frame
Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)3
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.
Time frame
Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)Secondary outcomes
1
Readmission Rates
Readmission Rates
Time frame
Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)2
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.
Time frame
Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)3
Number of Physicians Follow-Up Visits
Number of Physicians Follow-Up Visits
Time frame
Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)4
Number of Emergency Room Visits
Number of Emergency Room Visits
Time frame
Baseline, 4 weeks (T1), 8 weeks (T2), and 3-,6-,12-months post intervention (T3)Sponsors and contacts
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Source ClinicalTrials.gov