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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02703870

Enrollment

Registered

2016-03-09

Start date

2013-03-31

Completion date

2015-12-31

Last updated

2016-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemianopia, Stroke

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, ...)

Interventions

DEVICEverum tDCS

real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes

DEVICEsham tDCS

sham transcranial direct current stimulation, 10 sessions, for 20 minutes

BEHAVIORALVRT

Vision restoration training, 10 sessions, 20 minutes

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
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 latencies (ms) from baseline to post-intervention and follow up	14-20 days post treatment, 3 months follow up	VEP latencies (ms)
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

Countries

Austria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026