VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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
Secondary 9-hole Peg 6-weeks No

Sponsors