Upper Extremity ParesisNCT06288217
Non-invasive Trigeminal and Vagus Nerve Stimulation for Stroke Subjects With Chronic Upper Extremity Deficits
A study testing NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) and Upper Limb Rehabilitation in people with Upper Extremity Paresis and Stroke, Chronic, run by NeuraStasis, Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Upper Extremity Paresis, Stroke, Chronic
- What is being tested?
- NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) and Upper Limb Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 13 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of unilateral supratentorial ischemic, intracerebral hemorrhagic, subarachnoid hemorrhagic, or a heterogeneous lesion stroke that occurred at least 6 months but not more than 15 years prior to enrollment.
- Age >30 years and <85 years.
- Fugl-Meyer Assessment, Upper Limb (FMA-UE) baseline score of 10 to 56 (inclusive of 10 and 56).
- Ability to communicate, understand, and provide appropriate consent. Subjects should be able to follow two-step commands.
- Right- or left-sided weakness of the upper extremity.
Who cannot join
- Participant with any implanted metallic device at or near the stimulation sites (forehead and ears).
- Participant with an implanted or active stimulator (ex. Deep brain stimulator, pacemaker, vagus nerve stimulator, defibrillator)
- Participant skin in the stimulation area has open wounds, skin eruptions, swollen, infected, or inflamed areas, or skin abnormalities that could be cancerous
- Advanced cardiac, pulmonary, liver, kidney dysfunction or blood system disease
- Participant has a fever or shows clinical signs concerning for an infectious disease
- Other neurologic or musculoskeletal diseases that could interfere with the assessments of this study
Show all 17Show fewer
- Low heart rate (<60 bpm) from a cardiac conduction block or related etiology
- Participant has a history of trigeminal neuralgia
- Participant has a history of Bell's Palsy
- History of cranial nerve neuropathy (including facial nerve injury), carotid surgery, vagotomy, or other surgical intervention on the vagus nerve
- History of recurrent syncopal events
- Known or newly-discovered aneurysm or arteriovenous malformation
- Patients who have any terminal illness such that the patient would not be expected to survive more than 90 days
- Botox injections 12 weeks prior to or during therapy
- Participants who have had a craniectomy:
- Without replacement of bone flap
- With bone flap replaced < 6 months prior to initiation of study activities
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Feasibility of Trigeminal and Vagus Nerve Stimulation in Subjects With Chronic Upper Extremity Deficits After Stroke
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.
Read the detailed description
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.
- Conditions
- Upper Extremity Paresis, Stroke, Chronic
- Being tested
- NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation), Upper Limb Rehabilitation, Sham Stimulation
- Medical subject headings
- Paresis, Stroke, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation)Device
Also called nTVNS
Pulsed electrical stimulation of the trigeminal and vagus nerves paired with upper limb rehabilitation movements
Upper Limb RehabilitationOther
Rehabilitation movements to improve upper limb function after stroke
Sham StimulationOther
Control sham stimulation of the trigeminal and vagus nerves is delivered at the start of each session. Performed alongside standard-of-care rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Paired nTVNS Stimulation | Experimental | 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. Receives: Device: NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation); Other: Upper Limb Rehabilitation |
| Sham Stimulation | Sham comparator | 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. Receives: Other: Upper Limb Rehabilitation; Other: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 7 days of completing 6 weeks of rehabilitation
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Collected at each therapy session across 6 weeks of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start5 Mar 2024
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity ParesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuraStasis, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Savitz, MD, Principal investigator, The University of Texas Health Science Center, HoustonKirt Gill, MD, Study director, NeuraStasis, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288217
- Sponsor's protocol ID
- NS-CIP-001
- Status last verified
- May 2026
- First submitted
- 17 Feb 2024
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Trigeminal and Vagus Nerve Stimulation in Subjects With Chronic Upper Extremity Deficits After Stroke
- ClinicalTrials.gov ID
- NCT06288217
- Acronym / sponsor ID
- NS-CIP-001
- Conditions
- Upper Extremity Paresis, Stroke, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NeuraStasis, IncIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paired nTVNS Stimulation | Experimental | Device: NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation), Other: Upper Limb RehabilitationNon-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. |
| Sham Stimulation | Sham comparator | Other: Upper Limb Rehabilitation, Other: Sham StimulationFor 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. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of unilateral supratentorial ischemic, intracerebral hemorrhagic, subarachnoid hemorrhagic, or a heterogeneous lesion stroke that occurred at least 6 months but not more than 15 years prior to enrollment.
- Age >30 years and <85 years.
- Fugl-Meyer Assessment, Upper Limb (FMA-UE) baseline score of 10 to 56 (inclusive of 10 and 56).
- Ability to communicate, understand, and provide appropriate consent. Subjects should be able to follow two-step commands.
- Right- or left-sided weakness of the upper extremity.
Key exclusion criteria (17 listed)
- Participant with any implanted metallic device at or near the stimulation sites (forehead and ears).
- Participant with an implanted or active stimulator (ex. Deep brain stimulator, pacemaker, vagus nerve stimulator, defibrillator)
- Participant skin in the stimulation area has open wounds, skin eruptions, swollen, infected, or inflamed areas, or skin abnormalities that could be cancerous
- Advanced cardiac, pulmonary, liver, kidney dysfunction or blood system disease
- Participant has a fever or shows clinical signs concerning for an infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation)Also: nTVNSPulsed electrical stimulation of the trigeminal and vagus nerves paired with upper limb rehabilitation movements | Device | Paired nTVNS Stimulation |
| Upper Limb RehabilitationRehabilitation movements to improve upper limb function after stroke | Other | Paired nTVNS Stimulation, Sham Stimulation |
| Sham StimulationControl sham stimulation of the trigeminal and vagus nerves is delivered at the start of each session. Performed alongside standard-of-care rehabilitation. | Other | Sham Stimulation |
Primary outcome
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change
Time frame: Within 7 days of completing 6 weeks of rehabilitation
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).
8 secondary outcomes
Action Research Arm Test (ARAT) Average Change
Time frame: Within 7 days of completing 6 weeks of rehabilitation
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Response %
Time frame: Within 7 days of completing 6 weeks of rehabilitation
Proportion of subjects completing all pre-specified treatment doses
Time frame: Upon completion of 6 weeks of rehabilitation
Subject Questionnaire on Device Usage
Time frame: Upon completion of 6 weeks of rehabilitation
Therapist Questionnaire on Device Usage
Time frame: Upon completion of 6 weeks of rehabilitation
Serious adverse device effects (SADE) rate at 24 hours post-therapy session
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
Time frame: Within 7 days of completing 6 weeks of rehabilitation
Analysis of the number of stimulations per therapy session
Time frame: Collected at each therapy session across 6 weeks of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Savitz, MD principal investigator
The University of Texas Health Science Center, Houston
Kirt Gill, MD study director
NeuraStasis, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuraStasis Stimulator System (Non-Invasive Trigeminal and Vagus Nerve Stimulation) and Upper Limb Rehabilitation in people with Upper Extremity Paresis and Stroke, Chronic, run by NeuraStasis, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change (time frame: Within 7 days of completing 6 weeks of rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.