StrokePhase 2VaNSaRTSNCT05339893
Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke
A Phase 2 study testing In Motion Rehabilitation Robot in people with Stroke and Hemiparesis, run by Northwell Health at 1 site in United States.
Trial summary
To determine whether treatment with transauricular vagus nerve stimulation (taVNS) during the training of an affected upper limb of a patient with chronic stroke on a robotic motor task alters the motor impairment. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- In Motion Rehabilitation Robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 13 Apr 2026
- Phase
- Phase 2
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In receipt of full vaccination status and no recent upper respiratory symptoms and no loss of taste or olfaction.
- Individuals between 18 and 85 years of age
- First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
- Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
- Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist).
Who cannot join
- Recent fever or upper respiratory symptoms.
- Botox treatment within 3 months of enrollment
- Fixed contraction deformity in the affected limb
- Complete and total flaccid paralysis of all shoulder and elbow motor performance
- Prior injury to the vagus nerve
- Severe dysphagia
Show all 12Show fewer
- Introduction of any new rehabilitation interventions during study
- Individuals with scar tissue, broken skin, or irremovable metal piercings that may interfere with the stimulation or the stimulation device
- Highly conductive metal in any part of the body, including metal injury to the eye; this will be reviewed on a case by case basis for PI to make a determination
- Pregnant or plan on becoming pregnant or breastfeeding during the study period
- Significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI review)
- Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institutes at Northwell Health
Manhasset, New York, 11030
About this study
Official title: Evaluating the Use of Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training to Improve Upper Limb Motor Recovery After Stroke
To determine whether treatment with transauricular vagus nerve stimulation (taVNS) during the training of an affected upper limb of a patient with chronic stroke on a robotic motor task alters the motor impairment.
Read the detailed description
The investigators will evaluate whether transauricular vagus nerve stimulation (taVNS) delivered during extensor movements executed on a robotic device will alter the clinical measurement of upper limb motor performance in 45 patients with chronic stroke.
Patients will engage the robot first with their unaffected limb. This practice will ensure understanding and serve to activate the hemisphere ipsilateral to the impaired limb. Patients are likely to perform this activity quickly, there will not be any taVNS during this part of the procedure. Patients will then wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement.
- Conditions
- Stroke, Hemiparesis
- Being tested
- In Motion Rehabilitation Robot
- Keywords
- taVNS, Trans Auricular Vagus Nerve Stimulation, Robotic Training, Upper Limb Motor Recovery
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Motion Rehabilitation RobotDevice
Patients will wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement.
| Study group | Role | What they receive |
|---|---|---|
| Affected Limb | Sham comparator | Patients will wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement.
Within subject. Sham controlled. Double blind, the patient will not know whether they are receiving taVNS, all patients feel a ramp up current but only the active group will receive timed stimulation bursts during the robotic protocol that engages the affected limb. ' Receives: Device: In Motion Rehabilitation Robot |
| Unaffected limb | No intervention | Patients will engage the robot first with their unaffected limb. This practice will ensure understanding and serve to activate the hemisphere ipsilateral to the impaired limb. Patients are likely to perform this activity quickly, there will not be any taVNS during this part of the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Motor Scale for the upper extremity
A standard well characterized measure of the movement ability of the subjects arm- shoulder, elbow, wrist, hand and fingers.
Measured: 30-45minutes
Secondary outcomes (1)
Action Research Arm Test (ARAT)
A standard evaluation of 19 different real world actions of the arm, including movements around the shoulder, elbow, wrist, hand and fingers.
Measured: 30-45minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start12 Sep 2022
- Primary completion13 Apr 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To determine whether treatment with taVNS during the robotic training of a patient with stroke and a paralyzed arm will alter the motor impairment.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Volpe, Northwell Health
- Investigators
- Bruce T Volpe, MD, Principal investigator, Feinstein Center for Molecular MedicineTimir Datta Chaudhuri, PhD, Study director, Feinstein Center for Bioelectronic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339893
- Sponsor's protocol ID
- 21-1355
- Acronym
- VaNSaRTS
- Status last verified
- May 2025
- First submitted
- 29 Mar 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training to Improve Upper Limb Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT05339893
- Acronym / sponsor ID
- VaNSaRTS / 21-1355
- Conditions
- Stroke, Hemiparesis
- Keywords
- taVNS, Trans Auricular Vagus Nerve Stimulation, Robotic Training, Upper Limb Motor Recovery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 13 Apr 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 21 Apr 2022 (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.
To determine whether treatment with transauricular vagus nerve stimulation (taVNS) during the training of an affected upper limb of a patient with chronic stroke on a robotic motor task alters the motor impairment.
Detailed description
The investigators will evaluate whether transauricular vagus nerve stimulation (taVNS) delivered during extensor movements executed on a robotic device will alter the clinical measurement of upper limb motor performance in 45 patients with chronic stroke.
Patients will engage the robot first with their unaffected limb. This practice will ensure understanding and serve to activate the hemisphere ipsilateral to the impaired limb. Patients are likely to perform this activity quickly, there will not be any taVNS during this part of the procedure. Patients will then wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- To determine whether treatment with taVNS during the robotic training of a patient with stroke and a paralyzed arm will alter the motor impairment.
| Arm | Type | Receives |
|---|---|---|
| Affected Limb | Sham comparator | Device: In Motion Rehabilitation RobotPatients will wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement. Within subject. Sham controlled. Double blind, the patient will not know whether they are receiving taVNS, all patients feel a ramp up current but only the active group will receive timed stimulation bursts during the robotic protocol that engages the affected limb. ' |
| Unaffected limb | No intervention | –Patients will engage the robot first with their unaffected limb. This practice will ensure understanding and serve to activate the hemisphere ipsilateral to the impaired limb. Patients are likely to perform this activity quickly, there will not be any taVNS during this part of the procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In receipt of full vaccination status and no recent upper respiratory symptoms and no loss of taste or olfaction.
- Individuals between 18 and 85 years of age
- First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
- Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
- Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist).
Key exclusion criteria (12 listed)
- Recent fever or upper respiratory symptoms.
- Botox treatment within 3 months of enrollment
- Fixed contraction deformity in the affected limb
- Complete and total flaccid paralysis of all shoulder and elbow motor performance
- Prior injury to the vagus nerve
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 |
|---|---|---|
| In Motion Rehabilitation RobotPatients will wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement. | Device | Affected Limb |
Primary outcome
Fugl-Meyer Motor Scale for the upper extremity
Time frame: 30-45minutes
A standard well characterized measure of the movement ability of the subjects arm- shoulder, elbow, wrist, hand and fingers.
1 secondary outcome
Action Research Arm Test (ARAT)
Time frame: 30-45minutes
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 6 Oct 2026.
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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.
Bruce T Volpe, MD principal investigator
Feinstein Center for Molecular Medicine
Timir Datta Chaudhuri, PhD study director
Feinstein Center for Bioelectronic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing In Motion Rehabilitation Robot in people with Stroke and Hemiparesis, run by Northwell Health 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 12 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 6 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Motor Scale for the upper extremity (time frame: 30-45minutes). 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 6 Oct 2026.