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NCT06930716
Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
NA trial testing Transcutaneous vagus nerve stimulation (taVNS) in Consciousness Disorders in 15 participants. Currently enrolling.
30 December 2027
Quick facts
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 12 August 2025 |
| Primary completion | 30 December 2027 |
| Estimated completion | 30 December 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Transcutaneous vagus nerve stimulation (taVNS)
- Physical therapy using Hocoma
- Standard of Care
Conditions studied
- Consciousness Disorders — all drugs for Consciousness Disorders →
- Brain Injury — all drugs for Brain Injury →
- Altered Level of Consciousness — all drugs for Altered Level of Consciousness →
Sponsor
Icahn School of Medicine at Mount Sinai
Who can join
22 and older, any sex, with Consciousness Disorders or Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Use of Paired Vagus Nerve Stimulation in Mobilization of Patients with Prolonged Disorders of Consciousness: Protocol for a Single Cohort Open Label Interventional Study
Tosto-Mancuso J, Polizzi J, Dangayach NS, Rogers A, et al · · 2025 · DOI 10.1101/2025.07.24.25332147
Verify or expand the search:
- PubMed search for NCT06930716
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Consciousness Disorders
Currently open trials in the same condition.
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- NCT06389344 — Effect of Esketamine on Conscious State in Patients With pDoC · NA · recruiting
- NCT06744114 — Etiologies, Definitive Diagnosis and Patient Outcomes in Altered Level of Consciousness in the Emergency Department · active not recruiting
- NCT06426615 — Connectivity and Neural Signatures of Consciousness in Unresponsive States · NA · recruiting
- NCT06443827 — Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness · Phase 2 · active not recruiting
Other Icahn School of Medicine at Mount Sinai trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06930716 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai
- Last refreshed: 19 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06930716.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing