An interventional study of NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) and Upper Limb Rehabilitation in Upper Extremity Paresis and Stroke, Chronic, sponsored by NeuraStasis, Inc. Completed at 1 site in United States. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by NeuraStasis, Inc · Not applicable, Interventional, and Treatment
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.
This pilot study proceeded in two phases: Phase I, an unblinded stage, and Phase II, a blinded stage comparing intervention and sham groups.
Phase I consisted of 5 subjects, unblinded, receiving nTVNS. This phase tested the usability of the device and de-risked the use of nTVNS during rehabilitation. Visits included consent and baseline evaluation, followed by 6 weeks of treatment consisting of upper extremity rehabilitation paired with nTVNS. Rehabilitation and treatment occurred at a cadence of 3 sessions per week. Primary endpoints was collected after 6 weeks.
Phase II consisted of a Prospective Randomized Open, Blinded Endpoint (PROBE) design with 11 subjects randomized to an intervention nTVNS group or a control sham stimulation group. Both groups received a stimulation tolerability assessment at the start of each session to support blinding for therapists and subjects. For the sham group, no stimulation was delivered during the priming or rehabilitation portions of the session. The same evaluations, sessions, and endpoints occurred as those in Phase 1.
519 studies on the registry are indexed under Paresis; 111 are open to participants now.
This study's enrollment of 16 is below the median of 36 across 448 interventional studies indexed under Paresis.
Browse Paresis studies →This is the only study on the registry with NeuraStasis, Inc as lead sponsor.
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Exclusion Criteria
Participants who have had a craniectomy:
Non-invasive electrical stimulation of the trigeminal and vagus nerves will be delivered by the NeuraStasis Stimulator System. The non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear). The operator controls the stimulation delivery through the accompanying Controller. Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. A 15-minute priming stimulation is delivered next, followed by the standard of care rehabilitation over the remaining session. During this rehabilitation paired nTVNS is delivered with repetitive motions.
Device: NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) · Other: Upper Limb Rehabilitation
For the active sham comparator group, the non-invasive Stimulation Electrode is positioned on the head (forehead and in the ear) as in the experimental group. The operator controls the stimulation delivery through the accompanying Controller. Rehabilitation sessions begin with a stimulation tolerability assessment where the dose of therapy is selected. Following the tolerability assessment, the device delivers 0 mA stimulation during the priming period and rehabilitation.
Other: Upper Limb Rehabilitation · Other: Sham Stimulation
Pulsed electrical stimulation of the trigeminal and vagus nerves paired with upper limb rehabilitation movements
Also known as: nTVNS
Rehabilitation movements to improve upper limb function after stroke
Control sham stimulation of the trigeminal and vagus nerves is delivered at the start of each session. Performed alongside standard-of-care rehabilitation.
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change
The Fugl-Meyer Assessment, Upper Limb (FMA-UE) will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).
Time frame: Within 7 days of completing 6 weeks of rehabilitation
Action Research Arm Test (ARAT) Average Change
The ARAT will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. The ARAT is a widely used clinical scoring tool for stroke rehabilitation. The test consists of 19 items that are grouped into four sub-tests: grasp, grip, pinch, and gross movement. The total score on the ARAT ranges from 0 to 57, with a higher score indicating better performance.
Time frame: Within 7 days of completing 6 weeks of rehabilitation
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response %
The FMA-UE will be analyzed for the % of subjects that responded to treatment defined as achieving an effect equivalent to a greater than the minimal clinically important difference.
Time frame: Within 7 days of completing 6 weeks of rehabilitation
Proportion of subjects completing all pre-specified treatment doses
Proportion of subjects completing all pre-specified treatment sessions across the 6 weeks of rehabilitation
Time frame: Upon completion of 6 weeks of rehabilitation
Subject Questionnaire on Device Usage
A questionnaire that evaluates subjects' level of comfort during use of the device on a 5-point scale, with 5 being the most comfortable and 1 being the least comfortable.
Time frame: Upon completion of 6 weeks of rehabilitation
Therapist Questionnaire on Device Usage
A questionnaire that evaluates the ease of use of the device by therapists during the administration of rehab with the device on a 5-point scale, with 5 being the most usable and 1 being the least usable.
Time frame: Upon completion of 6 weeks of rehabilitation
Serious adverse device effects (SADE) rate at 24 hours post-therapy session
SADE rate at 24 hours post-therapy sessions
Time frame: Up to 24 hours after each therapy session and ending 24 hours post-last therapy session at 6 weeks of rehabilitation
Stroke impact scale (SIS) Domain and Summative Score Average Change
The Stroke Impact Scale (SIS) is a multidimensional self-reported measure of health-related quality of life. The SIS includes 59 items and assesses 8 domains: strength (four items), memory and thinking (seven items), emotion (nine items), communication (seven items), activities of daily living (ten items), mobility (nine items), hand function (five items) and participation and function in life activities (ten items). Each item is rated using a 5-point Likert-type scale (1 = an inability to complete the item; 5 = no difficulty experienced at all) and a global score is calculated as a summative score of each domain, transformed into a 0-100 scale. It includes an extra question on the person´s perceived stroke recovery measured in the form of a visual analogue scale from 0-100. Individual domain scores and the summative score will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline.
Time frame: Within 7 days of completing 6 weeks of rehabilitation
Analysis of the number of stimulations per therapy session
The number of paired stimulations initiated each rehabilitation session will be analyzed to understand personalized effectiveness and responder likelihood.
Time frame: Collected at each therapy session across 6 weeks of rehabilitation
Change in Communicative Effectiveness Index (CETI) Score
The Communicative Effectiveness Index (CETI) is a rating scale that measures change in functional communication in adults with aphasia. It assesses functionality across 16 communication situations rated by someone who interacts with the subject. The CETI score will be analyzed for the difference in average change after 6 weeks of therapy compared to baseline. Collected for subjects with aphasia only.
Time frame: Within 7 days of completing 6 weeks of rehabilitation
Plan to share: No
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