The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.
- Vagus Nerve Stimulation (VNS) Device
Other Names: VNS ARM 1: Kind: Experimental Label: VNS + Rehabilitation (1) Description: This group receives vagus nerve stimulation during rehabilitation. ARM 2: Kind: Experimental Label: VNS + Rehabilitation (2) - Comparator Description: This group receives rehabilitation and VNS, but the VNS is different than given in the other group. It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Upper Limb Fugl-Meyer (UEFM)||6-weeks||No|
|Primary||Wolf Motor Function Test (WMFT)||6-weeks||No|
|Secondary||Box and Block Test||6-weeks||No|