Stroke, Stroke Gait Rehabilitation, Upper Limb Deficit
Conditions
Keywords
vagus nerve stimulation, stroke rehabilitation, stroke related upper limb deficit
Brief summary
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
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale | 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 | 90 days post-operation | Percent change in FMA-LE from baseline to 90 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in Functional Assessment - 10-meter walk | 90 days post-operation | Absolute change in gait function as assessed by the timed 10-meter walk from baseline to 90 days |
| Percent Change in Functional Assessment - 10-meter walk | 90 days post-operation | Percent change in gait function as assessed by the timed 10-meter walk from baseline to 90 days |
| Absolute Change in Functional Assessment - 6-minute walk | 90 days post-operation | Absolute change in gait function as assessed by the 6-minute walk from baseline to 90 days |
| Percent Change in Functional Assessment - 6-minute walk | 90 days post-operation | Percent change in gait function as assessed by the 6-minute walk from baseline to 90 days |
| Absolute Change in Functional Assessment - Berg Balance Scale | 90 days post-operation | Absolute change in gait function as assessed by the Berg Balance Scale from baseline to 90 days |
| Percent Change in Functional Assessment - Berg Balance Scale | 90 days post-operation | Percent change in gait function as assessed by the Berg Balance Scale from baseline to 90 days |
| Absolute Change in Functional Assessment - Five Times Sit-to-Stand Test | 90 days post-operation | Absolute change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days |
| Percent Change in Functional Assessment - Five Times Sit-to-Stand Test | 90 days post-operation | Percent change in gait function as assessed by the Five Times Sit-to-Stand test from baseline to 90 days |
| Absolute Change in Functional Assessment - Stroke Impact Scale | 90 days post-operation | Absolute change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days |
| Percent Change in Functional Assessment - Stroke Impact Scale | 90 days post-operation | Percent change in gait function as assessed by the Stroke Impact Scale from baseline to 90 days |
| Absolute Change in Functional Assessment - 3D Motion Analysis of Gait | 90 days post-operation | Absolute change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days |
| Percent Change in Functional Assessment - 3D Motion Analysis of Gait | 90 days post-operation | Percent change in gait function as assessed by the 3D Motion Analysis of Gait from baseline to 90 days |
Countries
United States
Contacts
CONTACTEllen M Carl, PhD, CCRP
CONTACTAmylynn M Liskiewicz, MA, CCRP
PRINCIPAL_INVESTIGATORAssaf Berger, MD
University at Buffalo
Outcome results
None listed