NCT06288217

Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits

Feasibility of Trigeminal and Vagus Nerve Stimulation in Subjects With Chronic Upper Extremity Deficits After Stroke

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: NeuraStasis, Inc · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, pilot study of up to 25 subjects with residual upper extremity deficits at least six months after an ischemic stroke. The purpose of the study is to evaluate the initial 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. Subjects will either receive the intervention or control-sham stimulation. The study will inform the design and implementation of a pivotal study.

Detailed description

This pilot study will proceed in two phases: Phase I, an unblinded blinded stage and Phase II, a blinded stage comparing intervention and sham groups. Phase I will consist of 5 subjects, unblinded, receiving nTVNS. This phase will test the usability of the device and de-risk the use of nTVNS during rehabilitation. Visits will include consent and baseline evaluation followed by 6 weeks of treatment consisting of the standard of care with nTVNS. Rehabilitation and treatment will occur at a cadence of 3 sessions per week. Primary endpoints will be collected after 6 weeks. Phase II will consist of a Prospective Randomized Open, Blinded Endpoint (PROBE) design. Subjects will be randomized to an intervention nTVNS group or a control sham stimulation group. The control sham stimulation consists of standard-of-care rehabilitation with only a minimal amount of nTVNS delivered at the start of each session during a tolerability assessment intended to support further blinding for therapists and subjects. The same evaluations, sessions, and endpoints will occur as those in Phase I.

Conditions

• Stroke, Ischemic
• Upper Extremity Paresis

Interventions

Type	Name	Description
DEVICE	NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation)	Pulsed electrical stimulation of the trigeminal and vagus nerves paired with upper limb rehabilitation movements
OTHER	Upper Limb Rehabilitation	Rehabilitation movements to improve upper limb function after stroke
OTHER	Sham Stimulation	Control sham stimulation of the trigeminal and vagus nerves is delivered at the start of each session. Performed alongside standard-of-care rehabilitation.

Timeline

• Start date: 2024-03-05
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2024-03-01
• Last updated: 2024-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study