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

University of Magdeburg

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stroke; Hemianopia

Treatments: Behavioral: VRT; Device: sham tDCS; Device: verum tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT02703870

CES_NTG_1

Details and patient eligibility

About

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.

Full 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, ...)

Enrollment: 19 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 3 patient groups

Verum tDCS

Active Comparator group

Description:

Verum group receiving complete treatment of tDCS

Treatment:

Behavioral: VRT

Device: verum tDCS

sham tDCS

Sham Comparator group

Description:

Sham group receiving sham tDCS

Treatment:

Behavioral: VRT

Device: sham tDCS

real VRT

Active Comparator group

Description:

Real Vision Restoration Training

Treatment:

Device: sham tDCS

Device: verum tDCS