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

Study Overview
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Brief Summary
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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
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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, ...)

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

Conditions
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Hemianopia, Stroke

Intervention / Treatment
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* Device: verum tDCS
* Device: sham tDCS
* Behavioral: VRT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verum tDCS<br>Verum group receiving complete treatment of tDCS | Device: verum tDCS<br>* real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes<br>Behavioral: VRT<br>* Vision restoration training, 10 sessions, 20 minutes<br>|
| Sham Comparator: sham tDCS<br>Sham group receiving sham tDCS | Device: sham tDCS<br>* sham transcranial direct current stimulation, 10 sessions, for 20 minutes<br>Behavioral: VRT<br>* Vision restoration training, 10 sessions, 20 minutes<br>|
| Active Comparator: real VRT<br>Real Vision Restoration Training | Device: verum tDCS<br>* real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes<br>Device: sham tDCS<br>* sham transcranial direct current stimulation, 10 sessions, for 20 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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