Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hemianopia
- Sponsor
- University of Magdeburg
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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 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, ...)
Investigators
Bernhard A. Sabel
Prof. Dr.
University of Magdeburg
Eligibility Criteria
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
- •Visual Neglect
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- Change in VEP amplitudes (µV) from baseline to post-intervention and follow up(14-20 days post treatment, 3 months follow up)
- Change in network coherence from baseline to post-intervention and follow up(14-20 days post treatment, 3 months follow up)
- Number of participants with treatment-related adverse events assessed by a questionnaire(up to 4 months)
- Change in VEP latencies (ms) from baseline to post-intervention and follow up(14-20 days post treatment, 3 months follow up)