Upper Limb DeficitNCT07643337
Impact of VNS With Rehab on Gait Post-Stroke
A study testing Vagus Nerve Stimulation Therapy in people with Upper Limb Deficit and Stroke Gait Rehabilitation, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Upper Limb Deficit, Stroke Gait Rehabilitation, Stroke
- What is being tested?
- Vagus Nerve Stimulation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to 23 Feb 2028
- 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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy
- ≥22 years and ≤ 80 years
- Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits
- Residual active movement in the affected limb's thumb and other 2 fingers
- Stroke-related deficits in the lower limbs and gait with a Functional Ambulation Category (FAC) ≥3
- Able to follow simple instructions and independently walk short distances with or without external support or leg orthoses, but without manual contact with another person
Who cannot join
- Intact lower limb functions (Fugl-Meyer score=34)
- Not a candidate for VNS therapy according to FDA guidelines
- Pregnant patients
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
University at Buffalo Neurosurgery
Buffalo, New York, 14203
Ellen M Carl, PhD, CCRP, 716-218-1000 ext. 7260, ecarl@ubns.com
Amylynn M Liskiewicz, MA, CCRP, 716-218-1000, aliskiewicz@ubns.com
About this study
Official title: The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke
This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.
Read the detailed description
Stroke is a major cause of disability worldwide and currently there is a lack of effective treatments to improve functional capacity of patients with long-term disability. Vagus Nerve Stimulation (VNS) is FDA-approved for rehabilitation of upper limb deficits in patient with stroke. The device (including Vagus nerve electrodes and chest generator) is permanently implanted prior to the beginning of rehabilitation as standard of care. It is activated by patients and physical therapists during a period of 4.5 months of in-clinic and home therapy. However, so far there have been no approved neuromodulation treatments to improve lower limb functions and gait, which are key for patients' quality of life and their ability to integrate with work and social cycles.
This project will evaluate the impact of VNS on lower limb functions as measured by clinical and laboratory-based analyses of gait in stroke survivors. Patients with both upper and lower limb deficits will be included in this project. After the completion of the standard upper limb VNS-rehabilitation protocol, patients will be double-blindly randomized into 2 groups: a) lower limbs and gait rehabilitation with VNS ON for the duration of therapy; b) lower limbs and gait rehabilitation with VNS OFF.
Based on prior experience with upper limb deficits, we hypothesize that rehabilitation therapy coupled with VNS neuromodulation will elicit functional improvements in lower limb deficits and gait.
- Conditions
- Upper Limb Deficit, Stroke Gait Rehabilitation, Stroke
- Being tested
- Vagus Nerve Stimulation Therapy
- Keywords
- vagus nerve stimulation, stroke rehabilitation, stroke related upper limb deficit
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve Stimulation TherapyDevice
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
| Study group | Role | What they receive |
|---|---|---|
| VNS ON | Experimental | Receives active stimulation during therapy Receives: Device: Vagus Nerve Stimulation Therapy |
| VNS OFF | Sham comparator | No stimulation during therapy Receives: Device: Vagus Nerve Stimulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
Absolute change in FMA-LE from baseline to 90 days
Measured: 90 days post-operation
Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
Percent change in FMA-LE from baseline to 90 days
Measured: 90 days post-operation
Secondary outcomes (12)
Absolute Change in Functional Assessment - 10-meter walk
Absolute change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
Measured: 90 days post-operation
Percent Change in Functional Assessment - 10-meter walk
Percent change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
Measured: 90 days post-operation
Absolute Change in Functional Assessment - 6-minute walk
Absolute change in gait function as assessed by the 6-minute walk from baseline to 90 days
Measured: 90 days post-operation
Percent Change in Functional Assessment - 6-minute walk
Percent change in gait function as assessed by the 6-minute walk from baseline to 90 days
Measured: 90 days post-operation
Absolute Change in Functional Assessment - Berg Balance Scale
Absolute change in gait function as assessed by the Berg Balance Scale from baseline to 90 days
Measured: 90 days post-operation
Percent Change in Functional Assessment - Berg Balance Scale
Percent change in gait function as assessed by the Berg Balance Scale from baseline to 90 days
Measured: 90 days post-operation
Absolute Change in Functional Assessment - Five Times Sit-to-Stand Test
Absolute change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days
Measured: 90 days post-operation
Percent Change in Functional Assessment - Five Times Sit-to-Stand Test
Percent change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days
Measured: 90 days post-operation
Absolute Change in Functional Assessment - Stroke Impact Scale
Absolute change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days
Measured: 90 days post-operation
Percent Change in Functional Assessment - Stroke Impact Scale
Percent change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days
Measured: 90 days post-operation
Absolute Change in Functional Assessment - 3D Motion Analysis of Gait
Absolute change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days
Measured: 90 days post-operation
Percent Change in Functional Assessment - 3D Motion Analysis of Gait
Percent change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days
Measured: 90 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startJun 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion23 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb DeficitStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assaf Berger, State University of New York at Buffalo
- Investigators
- Assaf Berger, MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643337
- Sponsor's protocol ID
- STUDY00008984
- Status last verified
- May 2026
- First submitted
- 23 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: IPD will likely be shared but a plan has not yet been finalized.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07643337
- Acronym / sponsor ID
- STUDY00008984
- Conditions
- Upper Limb Deficit, Stroke Gait Rehabilitation, Stroke
- Keywords
- vagus nerve stimulation, stroke rehabilitation, stroke related upper limb deficit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 23 Feb 2028 (estimated)
- First posted
- 11 Jun 2026 (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 prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.
Detailed description
Stroke is a major cause of disability worldwide and currently there is a lack of effective treatments to improve functional capacity of patients with long-term disability. Vagus Nerve Stimulation (VNS) is FDA-approved for rehabilitation of upper limb deficits in patient with stroke. The device (including Vagus nerve electrodes and chest generator) is permanently implanted prior to the beginning of rehabilitation as standard of care. It is activated by patients and physical therapists during a period of 4.5 months of in-clinic and home therapy. However, so far there have been no approved neuromodulation treatments to improve lower limb functions and gait, which are key for patients' quality of life and their ability to integrate with work and social cycles.
This project will evaluate the impact of VNS on lower limb functions as measured by clinical and laboratory-based analyses of gait in stroke survivors. Patients with both upper and lower limb deficits will be included in this project. After the completion of the standard upper limb VNS-rehabilitation protocol, patients will be double-blindly randomized into 2 groups: a) lower limbs and gait rehabilitation with VNS ON for the duration of therapy; b) lower limbs and gait rehabilitation with VNS OFF.
Based on prior experience with upper limb deficits, we hypothesize that rehabilitation therapy coupled with VNS neuromodulation will elicit functional improvements in lower limb deficits and gait.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VNS ON | Experimental | Device: Vagus Nerve Stimulation TherapyReceives active stimulation during therapy |
| VNS OFF | Sham comparator | Device: Vagus Nerve Stimulation TherapyNo stimulation during therapy |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy
- ≥22 years and ≤ 80 years
- Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits
- Residual active movement in the affected limb's thumb and other 2 fingers
- Stroke-related deficits in the lower limbs and gait with a Functional Ambulation Category (FAC) ≥3
Key exclusion criteria (3 listed)
- Intact lower limb functions (Fugl-Meyer score=34)
- Not a candidate for VNS therapy according to FDA guidelines
- Pregnant patients
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 TherapyImplanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA) | Device | VNS OFF, VNS ON |
Primary outcome
Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
Time frame: 90 days post-operation
Absolute change in FMA-LE from baseline to 90 days
Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale
Time frame: 90 days post-operation
Percent change in FMA-LE from baseline to 90 days
12 secondary outcomes
Absolute Change in Functional Assessment - 10-meter walk
Time frame: 90 days post-operation
Percent Change in Functional Assessment - 10-meter walk
Time frame: 90 days post-operation
Absolute Change in Functional Assessment - 6-minute walk
Time frame: 90 days post-operation
Percent Change in Functional Assessment - 6-minute walk
Time frame: 90 days post-operation
Absolute Change in Functional Assessment - Berg Balance Scale
Time frame: 90 days post-operation
Percent Change in Functional Assessment - Berg Balance Scale
Time frame: 90 days post-operation
Absolute Change in Functional Assessment - Five Times Sit-to-Stand Test
Time frame: 90 days post-operation
Percent Change in Functional Assessment - Five Times Sit-to-Stand Test
Time frame: 90 days post-operation
Absolute Change in Functional Assessment - Stroke Impact Scale
Time frame: 90 days post-operation
Percent Change in Functional Assessment - Stroke Impact Scale
Time frame: 90 days post-operation
Absolute Change in Functional Assessment - 3D Motion Analysis of Gait
Time frame: 90 days post-operation
Percent Change in Functional Assessment - 3D Motion Analysis of Gait
Time frame: 90 days post-operation
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 11 Jun 2026.
- Individual participant dataSharing planned: Undecided. IPD will likely be shared but a plan has not yet been finalized.
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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.
Assaf Berger, MD principal investigator
University at Buffalo
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 Therapy in people with Upper Limb Deficit and Stroke Gait Rehabilitation, run by State University of New York at Buffalo 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 6 inclusion and 3 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 11 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?
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 Ellen M Carl, PhD, CCRP (716-218-1000 ext. 7260, ecarl@ubns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale (time frame: 90 days post-operation). The study lists 2 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 11 Jun 2026.