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NCT06930716 · ClinicalTrials.gov registry record · NA
Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
A NA study of Brain Injury and Consciousness Disorders, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06930716: Recruiting NA study of Brain Injury and Consciousness Disorders, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06930716 is a NA study of Brain Injury and Consciousness Disorders that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 15 participants, below the 5,189-participant average among 10 other Brain Injury trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06930716, a NA study of Brain Injury and Consciousness Disorders, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL Standard of Care
- DEVICE Transcutaneous vagus nerve stimulation (taVNS)
- DEVICE Physical therapy using Hocoma
Study Locations (1)
New York
- Abilities Research Center, Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-08-12 |
| Est. Completion | 2027-12-30 |
| Phase | NA |
What NCT06930716 shows while recruiting
NCT06930716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 5,189-participant average among 10 other Brain Injury trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Brain Injury appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.
NCT06930716 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06930716 about?
NCT06930716 is a clinical study titled "Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness". 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 pro...
What is the current status of trial NCT06930716?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-08-12. Estimated completion is 2027-12-30.
What conditions does trial NCT06930716 study?
This clinical trial studies the following conditions: Brain Injury, Consciousness Disorders, Altered Level of Consciousness.
What interventions are being tested in trial NCT06930716?
The interventions under investigation include: Standard of Care (BEHAVIORAL), Transcutaneous vagus nerve stimulation (taVNS) (DEVICE), Physical therapy using Hocoma (DEVICE).
Who is sponsoring clinical trial NCT06930716?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06930716 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06930716's enrollment target sits among peer trials
15 11th of 10 the lowest of 10 other Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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