Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits
NCT: NCT06288217 · COMPLETED
Brief Summary
This is a single-center, multiphase pilot study of 16 subjects with residual upper extremity deficits at least six months after a supratentorial ischemic or hemorrhagic stroke. The purpose of the study is to evaluate the clinical safety, device functionality, and treatment effect of non-invasive electrical stimulation of the trigeminal and/or vagus nerves (nTVNS) using the NeuraStasis Stimulator System adjunctive to rehabilitation. Phase 1 consisted of 5 unblinded subjects receiving nTVNS to assess device usability and safety. Phase 2 used a Prospective Randomized Open, Blinded Endpoint (PROBE) design comparing nTVNS to sham stimulation in 11 subjects. The study will inform the design and implementation of a pivotal study.
Frequently Asked Questions
What is Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits?
Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits is a clinical trial registered under NCT06288217. Current status: COMPLETED.
What is the status of NCT06288217?
The current status of NCT06288217 (Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits) is: COMPLETED.
When did Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits start?
Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits started on 2024-03-05.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.