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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2015

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, …)

Interventions

  • Device: verum tDCS
    • real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes
  • Device: sham tDCS
    • sham transcranial direct current stimulation, 10 sessions, for 20 minutes
  • Behavioral: VRT
    • Vision restoration training, 10 sessions, 20 minutes

Arms, Groups and Cohorts

  • Active Comparator: Verum tDCS
    • Verum group receiving complete treatment of tDCS
  • Sham Comparator: sham tDCS
    • Sham group receiving sham tDCS
  • Active Comparator: real VRT
    • Real Vision Restoration Training

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Posterior Cerebral Artery Stroke – Visual Field Defect – Lesion age 4 weeks up to 6 month max. Exclusion Criteria:

  • Electrical Implants – Metal artefacts in head – Epilepsy – Visual Neglect

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Magdeburg
  • Collaborator
    • Neurologisches Therapiezentrum Gmundnerberg
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bernhard A. Sabel, Prof. Dr. – University of Magdeburg
  • Overall Official(s)
    • Bernhard A Sabel, Prof. Dr., Study Director, Institute of Medical Psychology

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