Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study
Keywords
Abstract
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, ...)
Dates
| Last Verified: | 02/29/2016 |
| First Submitted: | 09/17/2015 |
| Estimated Enrollment Submitted: | 03/02/2016 |
| First Posted: | 03/08/2016 |
| Last Update Submitted: | 03/02/2016 |
| Last Update Posted: | 03/08/2016 |
| Actual Study Start Date: | 02/28/2013 |
| Estimated Primary Completion Date: | 11/30/2015 |
| Estimated Study Completion Date: | 11/30/2015 |
Condition or disease
Intervention/treatment
Device: verum tDCS
Device: sham tDCS
Behavioral: VRT
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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 |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 - Epilepsy - Visual Neglect |
Outcome
Primary Outcome Measures
1. 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
1. 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]
2. Change in VEP latencies (ms) from baseline to post-intervention and follow up [14-20 days post treatment, 3 months follow up]
3. Change in VEP amplitudes (µV) from baseline to post-intervention and follow up [14-20 days post treatment, 3 months follow up]
4. Change in network coherence from baseline to post-intervention and follow up [14-20 days post treatment, 3 months follow up]
5. Number of participants with treatment-related adverse events assessed by a questionnaire [up to 4 months]
