Combining Non-Invasive Vagus Nerve Stimulation and Robotic Training in Upper Limb-Impaired Chronic Stroke Patients

Recruiting

Phase N/A Results N/A

Trial Description

Previous studies suggested that both robot-assisted rehabilitation and non-invasive vagus nerve stimulation can improve upper limb function in chronic stroke patients. Aim of present study is to explore whether the combination of these two approaches might enhance their positive effects on motor recovery. Safety and efficacy of this combination will be assessed within a proof-of-principle, double-blinded, randomized, sham-controlled trial. Transcutaneous vagus nerve stimulation (tVNS) will be delivered at left ear, in order to improve the response to the following robot-assisted therapy. Patients with both ischemic and hemorrhagic chronic stroke will be randomized to robot-assisted therapy associated with real or sham tVNS, delivered for 10 working days. Change in Fugl-Meyer has been chosen as primary outcome, while changes in several quantitative indicators of motor performance extracted by the robot as secondary outcomes.

Conditions

Interventions

  • Transcutaneous vagal nerve stimulation Device
    Intervention Desc: The stimulation of the auricular branch of the vagus nerve will be performed through an electric stimulator and two Ag-AgCl electrodes placed in the left external acoustic meatus at the inner side of the tragus. For sham stimulation, electrodes will be attached to the left ear lobe. tVNS will be delivered as trains lasting 30 s and composed by 600 pulses (intra-train pulse frequency = 20 Hz; pulse duration = 0.3 ms) repeated every 5 min for 60 min. The intensity of stimulation will individually adjusted to a level ranging above the detection threshold and below the pain threshold. In this range, when possible, the investigators will chose an intensity of 8 mA. Each day, for 10 consecutive working days, each patient will receive a session of robotic therapy following the real or sham tVNS stimulation
    ARM 1: Kind: Experimental
    Label: Robotic therapy and real tVNS
    Description: This group receives REAL vagus nerve stimulation before robotic rehabilitation.
    ARM 2: Kind: Experimental
    Label: Robotic therapy and sham tVNS
    Description: This group receives SHAM VNS before robotic rehabilitation. Sham VNS is not effective. Both groups receive the same amount of robotic rehabilitation.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in Fugl-Meyer Score immediately, one months and three months after the intervention No
Secondary Change in kinematic data (Motion Accuracy) measured by the robot immediately, one months and three months after the intervention No
Secondary Change in kinematic data (Motion Direction) measured by the robot immediately, one months and three months after the intervention No
Secondary Change in kinematic data (Smoothness) measured by the robot immediately, one months and three months after the intervention No
Secondary Change in kinematic data (Speed) measured by the robot immediately, one months and three months after the intervention No
Secondary Change in kinematic data (Movement Duration) measured by the robot immediately, one months and three months after the intervention No
Secondary Change in kinematic data (Efficiency) measured by the robot immediately, one months and three months after the intervention No
Secondary Incidence of adverse events that are related to treatment intervention period of 10 consecutive working days Yes

Sponsors