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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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 Summary:

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, ...)


Sponsor: University of Magdeburg

Current Primary Outcome: Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up [ Time Frame: 14-20 days post treatment, 3 months follow up ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in power spectra (Volts-squared per Hz (V^2/Hz) from baseline to post-intervention and follow up [ Time Frame: 14-20 days post treatment, 3 months follow up ]
    power spectra (Volts-squared per Hz (V^2/Hz)
  • Change in VEP latencies (ms) from baseline to post-intervention and follow up [ Time Frame: 14-20 days post treatment, 3 months follow up ]
    VEP latencies (ms)
  • Change in VEP amplitudes (µV) from baseline to post-intervention and follow up [ Time Frame: 14-20 days post treatment, 3 months follow up ]
    VEP amplitudes (µV)
  • Change in network coherence from baseline to post-intervention and follow up [ Time Frame: 14-20 days post treatment, 3 months follow up ]
    network coherence correlations
  • Number of participants with treatment-related adverse events assessed by a questionnaire [ Time Frame: up to 4 months ]
    questionnaire recording adverse effects


Original Secondary Outcome: Same as current

Information By: University of Magdeburg

Dates:
Date Received: September 18, 2015
Date Started: March 2013
Date Completion:
Last Updated: March 3, 2016
Last Verified: March 2016