Ischemic StrokeNCT07291024
A Study Of Vagus Nerve Stimulation (VNS) With Mobility Training For Gait Recovery After Chronic Ischemic Stroke
A study testing Vagus nerve stimulation (VNS) paired with mobility training in people with Ischemic Stroke, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, feasibility, and efficacy of vagus nerve stimulation (VNS) paired with mobility training to improve lower extremity function and gait in individuals with chronic ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Vagus nerve stimulation (VNS) paired with mobility training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2025to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Ischemic stroke ≥6 months prior to enrollment.
- Post-stroke lower extremity impairment defined as gait velocity of less than 0.8 m/s on a 10-meter walk test
- Provision of informed consent
Who cannot join
- Intracerebral Hemorrhage
- Active or prior psychosis or substance abuse within two years.
- Pre-stroke modified Rankin Scale (mRS) 3-5.
- Unable to participate in in-clinic rehabilitation.
- Preexisting neurological disorders affecting gait and mobility, such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, major head trauma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Neurosurgery Research Team, 507-293-1283
Rushna Ali, MD
About this study
Official title: Vagus Nerve Stimulation (VNS) Paired With Mobility Training For Gait Recovery After Chronic Ischemic Stroke With Integration Of Biomarker Assessment
The purpose of this study is to evaluate the safety, feasibility, and efficacy of vagus nerve stimulation (VNS) paired with mobility training to improve lower extremity function and gait in individuals with chronic ischemic stroke.
- Conditions
- Ischemic Stroke
- Being tested
- Vagus nerve stimulation (VNS) paired with mobility training
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulation (VNS) paired with mobility trainingOther
Participants will complete a 6-week in-clinic therapy phase (3 sessions per week), where a physical therapist will lead mobility training with VNS delivered via a handheld magnet. This will be followed by a 6-week at-home phase where participants continue daily exercises and VNS use, supported by weekly video calls to review at home rehabilitation activity and wearable activity monitors for remote monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Chronic ischemic stroke | Experimental | Participants with chronic ischemic stroke will be treated with a combination of vagus nerve stimulation and mobility training. Receives: Other: Vagus nerve stimulation (VNS) paired with mobility training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious adverse events related to vagus nerve stimulation or therapy
Total number of serious adverse events reported related to vagus nerve stimulation (VNS) or mobility training
Measured: 1 year
Number of participants to complete the study
Total number of participants to complete a minimum of 18 therapy sessions
Measured: 1 year
Change in Instrumented Gait Assessment score
Gait speed is calculated as the predetermined distance divided by the time to walk that distance, reported in meters per second (m/s). Improvement in gait velocity is ≥0.05 m/s .
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start3 Dec 2025
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rushna Ali, Mayo Clinic
- Investigators
- Rushna Ali, MD, Principal investigator, Mayo ClinicMuhib Khan, MD, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291024
- Sponsor's protocol ID
- 25-008515
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation (VNS) Paired With Mobility Training For Gait Recovery After Chronic Ischemic Stroke With Integration Of Biomarker Assessment
- ClinicalTrials.gov ID
- NCT07291024
- Acronym / sponsor ID
- 25-008515
- Conditions
- Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Dec 2025 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 18 Dec 2025 (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.
The purpose of this study is to evaluate the safety, feasibility, and efficacy of vagus nerve stimulation (VNS) paired with mobility training to improve lower extremity function and gait in individuals with chronic ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic ischemic stroke | Experimental | Other: Vagus nerve stimulation (VNS) paired with mobility trainingParticipants with chronic ischemic stroke will be treated with a combination of vagus nerve stimulation and mobility training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Ischemic stroke ≥6 months prior to enrollment.
- Post-stroke lower extremity impairment defined as gait velocity of less than 0.8 m/s on a 10-meter walk test
- Provision of informed consent
Key exclusion criteria (5 listed)
- Intracerebral Hemorrhage
- Active or prior psychosis or substance abuse within two years.
- Pre-stroke modified Rankin Scale (mRS) 3-5.
- Unable to participate in in-clinic rehabilitation.
- Preexisting neurological disorders affecting gait and mobility, such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia, major head trauma.
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 |
|---|---|---|
| Vagus nerve stimulation (VNS) paired with mobility trainingParticipants will complete a 6-week in-clinic therapy phase (3 sessions per week), where a physical therapist will lead mobility training with VNS delivered via a handheld magnet. This will be followed by a 6-week at-home phase where participants continue daily exercises and VNS use, supported by weekly video calls to review at home rehabilitation activity and wearable activity monitors for remote monitoring. | Other | Chronic ischemic stroke |
Primary outcome
Number of serious adverse events related to vagus nerve stimulation or therapy
Time frame: 1 year
Total number of serious adverse events reported related to vagus nerve stimulation (VNS) or mobility training
Number of participants to complete the study
Time frame: 1 year
Total number of participants to complete a minimum of 18 therapy sessions
Change in Instrumented Gait Assessment score
Time frame: Baseline, 12 months
Gait speed is calculated as the predetermined distance divided by the time to walk that distance, reported in meters per second (m/s). Improvement in gait velocity is ≥0.05 m/s .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Rushna Ali, MD principal investigator
Mayo Clinic
Muhib Khan, MD, MBBS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus nerve stimulation (VNS) paired with mobility training in people with Ischemic Stroke, run by Mayo Clinic 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Feb 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neurosurgery Research Team (507-538-6563, heaser.olyvia@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of serious adverse events related to vagus nerve stimulation or therapy (time frame: 1 year). The study lists 3 primary outcomes in all. 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 17 Feb 2026.