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

Phase 1

Completed

• Conditions: Hemianopia; Stroke
• Interventions: Device: verum tDCS; Device: sham tDCS; Behavioral: VRT

• Registration Number: NCT02703870
• Lead Sponsor: University of Magdeburg

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, ...)

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2015-09-18
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Study First Posted: 2016-03-09
• Last Update Posted: 2016-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum tDCS	VRT	Verum group receiving complete treatment of tDCS
real VRT	verum tDCS	Real Vision Restoration Training
sham tDCS	VRT	Sham group receiving sham tDCS
Verum tDCS	verum tDCS	Verum group receiving complete treatment of tDCS
sham tDCS	sham tDCS	Sham group receiving sham tDCS
real VRT	sham tDCS	Real Vision Restoration Training

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Inst. f. Medical Psychology, Univ. of Magdeburg; 🇩🇪 Magdeburg, Germany

Neurologisches Therapiezentrum Gmundnerberg; 🇦🇹 Altmuenster, Austria