Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot 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: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2013

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. Seven post-acute stroke homonymous hemianopia patients were assigned to 10 sessions of combined tDCS (2mA, 10 daily sessions of 15-20 min) and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds in percent. The results were compared to 7 age and stroke lesion matched controls of our patient data pool who received standard rehabilitation.

Interventions

  • Device: tDCS
    • Device: verum tDCS real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes Behavioral: VRT Vision restoration training, 10 sessions, 20 minutes
  • Behavioral: Standard rehabilitation
    • Standard rehabilitation procedures involving PC-based training of saccades and visual exploration

Arms, Groups and Cohorts

  • Active Comparator: tDCS
    • group receiving complete treatment of transcranial direct current stimulation
  • Active Comparator: Standard rehabilitation
    • Standard rehabilitation procedures

Clinical Trial Outcome Measures

Primary Measures

  • Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention
    • Time Frame: 14-20 days post treatment,

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, Professor – University of Magdeburg
  • Overall Official(s)
    • Raimund Alber, MS, Principal Investigator, Neurologisches Therapiezentrum Gmundnerberg

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