Combined Brain and Peripheral Nerve Stimulation for Stroke

Recruiting

Phase N/A Results N/A

Trial Description

Cerebrovascular disease is a major cause of disability worldwide. The catastrophic burden of stroke is more dramatic in low- and middle- income countries, and the scarcity of evidence-based rehabilitation interventions represents a major challenge to global health care. Upper limb weakness is frequent after stroke, but there is no universally accepted treatment to effectively improve hand function in patients with moderate and severe motor impairment. These are the patients in deepest need of rehabilitative interventions. This project addresses this important issue, by testing effects of a novel approach. We will non-invasively stimulate the brain and peripheral nerves in order to enhance effects of motor training aided by an electrical stimulation device in patients with moderate to severe hand weakness. Our hypothesis is that brain stimulation, when added to peripheral nerve stimulation, will enhance effects of motor training to a greater extent than brain stimulation alone, peripheral stimulation alone, or no stimulation.

Detailed Description

The goal of this study is to compare the effects of FES in close association with either transcranial direct current stimulation (tDCS) alone, peripheral nerve stimulation (PNS)alone, tDCS + PNS or sham tDCS + sham PNS, in patients with moderate to severe upper limb weakness, in a cross-over design. The working hypothesis of this proof-of-principle study is that either tDCS or PNS will enhance effects of functional electrical stimulation (FES) to a greater extent than placebo tDCS and PNS, and that the combination of tDCS and PNS will further improve motor outcomes than either tDCS or PNS alone.
The interventions will consist of outpatient motor training of the paretic wrist with FES in four experimental sessions separated by two weeks. In each session, either active tDCS + sham PNS, active PNS + sham tDCS,active tDCS + active PNS or sham tDCS + sham PNS will be applied. PNS will be applied for 2 hours and tDCS will be applied in the last 20 minutes before completion of PNS. The order of the sessions will be randomized across patients. Before the first session, patients will be familiarized with the FES device.

Conditions

Interventions

  • Active tDCS and active PNS Other
    Other Names: Transcranial direct current stimulation; Peripheral nerve stimulation
    Intervention Desc: Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA). Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.
    ARM 1: Kind: Experimental
    Label: Active tDCS and active PNS
    Description: 1 SESSION OF ACTIVE TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS)OF THE HEMISPHERE AFFECTED BY THE STROKE AND ACTIVE PERIPHERAL NERVE STIMULATION
  • Active tDCS and sham PNS Other
    Intervention Desc: Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA). In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.
    ARM 1: Kind: Experimental
    Label: Active tDCS and sham PNS
    Description: 1 SESSION OF ACTIVE TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS)OF THE HEMISPHERE AFFECTED BY THE STROKE AND SHAM PERIPHERAL NERVE STIMULATION
  • Sham tDCS and active PNS Other
    Intervention Desc: In sham tDCS, no current will be delivered through the tDCS device. Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.
    ARM 1: Kind: Experimental
    Label: Sham tDCS and active PNS
    Description: 1 SESSION OF SHAM TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS)OF THE HEMISPHERE AFFECTED BY THE STROKE AND ACTIVE PERIPHERAL NERVE STIMULATION
  • Sham tDCS and sham PNS Other
    Intervention Desc: No current will be delivered by the tDCS device, or to the radial, ulnar and median nerves.
    ARM 1: Kind: Experimental
    Label: Sham tDCS and sham PNS
    Description: 1 SESSION OF SHAM TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS)OF THE HEMISPHERE AFFECTED BY THE STROKE AND SHAM PERIPHERAL NERVE STIMULATION

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Endpoint: Bio-equivalence Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Active range of motion of wrist extension in the paretic side 2 weeks No

Sponsors