Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VNS ON | Experimental | Receives active stimulation during therapy |
|
| VNS OFF | Sham Comparator | No stimulation during therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagus Nerve Stimulation Therapy | Device | Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale | Absolute change in FMA-LE from baseline to 90 days | 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 | 90 days post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days post-operation |
| Percent Change in Functional Assessment - 10-meter walk |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ellen M Carl, PhD, CCRP | Contact | 716-218-1000 | 7260 | ecarl@ubns.com |
| Amylynn M Liskiewicz, MA, CCRP | Contact | 716-218-1000 | aliskiewicz@ubns.com |
| Name | Affiliation | Role |
|---|---|---|
| Assaf Berger, MD | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo Neurosurgery | Recruiting | Buffalo | New York | 14203 | United States |
IPD will likely be shared but a plan has not yet been finalized.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Percent change in gait function as assessed by the timed 10-meter walk from baseline to 90 days
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 90 days post-operation |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |