Electrical stimulation for Restoration of Vision after stroke (REVIS) in the damaged visual field after stroke

Not Applicable

• Conditions: Electrical stimulation for Restoration of Vision after stroke (REVIS) in the damaged visual field after stroke; H53.4; Visual field defects

• Registration Number: DRKS00005949
• Lead Sponsor: Institut für Medizinische Psychologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2015-02-02
• Study Start: 2016-06-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Prerequisite for participation in the study is a postchiasmatische lesion of the visual pathway with resultant unilateral visual field defect ( Quadrantenanopsie , hemianopia ) after ischemic or hemorrhagic stroke in persons aged 18 to 75 years.
For all participants in the study, the postchiasmatische lesion must be at least 6 months old. The visual field defect must be in the comparison of screening and baseline survey to be stable for so that any possible visual field improvements can be clearly attributed to the stimulation and not to a spontaneous recovery of visual acuity or spontaneous fluctuations in performance.

The study participants have residual visual performance and typically a gradual transition between the blind area ( visual field loss ) and the intact area of the visual field. The corrected visual acuity in each eye of the participant at least 0.4 ( logMAR ) or 20 /50 ( Snellen ).

Exclusion Criteria

Only subjects included in the study which do not fulfill any of the following exclusion criteria : active malignant tumors , diseases of the eyes or of the central nervous system that interfere with the study ( also includes uncontrolled glaucoma ) , electrical or electronic implants (eg pacemakers) ; metallic artifacts in the eye or the head ( with the exception of dental prostheses and shunts) ; expected low compliance ( for example, as a result of psychiatric or alcohol disorder or dementia syndrome); epilepsy disease within the last 10 years , intake of antiepileptic drugs or sedatives ; are pregnant or breastfeeding women.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
increase acuity in the visual field test (High Resolution Perimetry, HRP)<br><br>to weeks after the beginning of treatment

Secondary Outcome Measures

Name	Time	Method
reaction time HRP (High Risk Perimetrie) in ms, increase in mean threshold as parameter of coventionel perimetry, <br><br>EEG-power spectrum (electroencephalogram-power spectrum), reading test (International reading Speed texts - IRest)