Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study

Completed

Phase 1/2 Results N/A

Trial Description

The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.

Detailed Description

Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment.
19 post-acute stroke homonymous hemianopia patients were randomly assigned to either 10 sessions of combined rea-tDCS (2mA, 10 daily sessions of 15-20 min) and VRT, or sham-tDCS and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds. Secondary outcome is neurophysiological changes in EEG measures (VEP, Connectivity, Spectral Power, ...)

Conditions

Interventions

  • Sham tDCS Device
    Intervention Desc: sham transcranial direct current stimulation, 10 sessions, for 20 minutes
    ARM 1: Kind: Experimental
    Label: sham tDCS
    Description: Sham group receiving sham tDCS
    ARM 2: Kind: Experimental
    Label: real VRT
    Description: Real Vision Restoration Training
  • Verum tDCS Device
    Intervention Desc: real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes
    ARM 1: Kind: Experimental
    Label: Verum tDCS
    Description: Verum group receiving complete treatment of tDCS
    ARM 2: Kind: Experimental
    Label: real VRT
    Description: Real Vision Restoration Training
  • VRT Behavioral
    Intervention Desc: Vision restoration training, 10 sessions, 20 minutes
    ARM 1: Kind: Experimental
    Label: Verum tDCS
    Description: Verum group receiving complete treatment of tDCS
    ARM 2: Kind: Experimental
    Label: sham tDCS
    Description: Sham group receiving sham tDCS

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up 14-20 days post treatment, 3 months follow up No
Secondary Change in power spectra (Volts-squared per Hz (V^2/Hz) from baseline to post-intervention and follow up 14-20 days post treatment, 3 months follow up No
Secondary Change in VEP latencies (ms) from baseline to post-intervention and follow up 14-20 days post treatment, 3 months follow up No
Secondary Change in VEP amplitudes (┬ÁV) from baseline to post-intervention and follow up 14-20 days post treatment, 3 months follow up No
Secondary Change in network coherence from baseline to post-intervention and follow up 14-20 days post treatment, 3 months follow up No
Secondary Number of participants with treatment-related adverse events assessed by a questionnaire up to 4 months No

Sponsors