Impact of VNS With Rehab on Gait Post-Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vagus Nerve Stimulation Therapy.
- Who it may be relevant to
- Registry conditions: Upper Limb Deficit, Stroke Gait Rehabilitation, Stroke. Basic parameters: 22 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke
Overview
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.
Interventions
- Device Vagus Nerve Stimulation Therapy
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
Primary outcome measures
- Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale [Time frame: 90 days post-operation]
- Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale [Time frame: 90 days post-operation]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Intact lower limb functions (Fugl-Meyer score=34)
- Not a candidate for VNS therapy according to FDA guidelines
- Pregnant patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University at Buffalo Neurosurgery — Buffalo
Identifiers
NCT: NCT07643337 · STUDY00008984