Clinical Trial: Trial of Alternating Current Stimulation in Optic Neuropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial

Brief Summary: Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions within the defective visual field sectors of the visual field (primary outcome measure).

Detailed Summary: In a prospective, double-blind, randomized, placebo-controlled clinical trial 22 patients with optic nerve damage were randomly assigned to a rtACS- (n=12) or placebo-group (n=10). Visual field measures, visual acuity and EEG-recordings were collected before and after a daily 20-40min treatment for 10-days and at a 2-months-follow-up. Primary outcome measure was detection accuracy (DA) in defective visual field sectors of computer-based high resolution perimetry (HRP). Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.
Sponsor: University of Magdeburg

Current Primary Outcome: Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors [ Time Frame: Initial diagnostics (baseline), Post diagnostics ]

Central visual fields were assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.


Original Primary Outcome: Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors [ Time Frame: Nov 2006 - Dec 2010 ]

Central visual fields were assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.


Current Secondary Outcome: Other Visual and EEG Parameters [ Time Frame: Nov 2006 - Dec 2010 ]

Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.


Original Secondary Outcome: Same as current

Information By: University of Magdeburg

Dates:
Date Received: January 3, 2011
Date Started: November 2006
Date Completion:
Last Updated: September 4, 2013
Last Verified: September 2013