Skip to main content
Clinical Trials/NCT01270126
NCT01270126
Completed
Not Applicable

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

University of Magdeburg1 site in 1 country22 target enrollmentNovember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Optic Nerve Diseases
Sponsor
University of Magdeburg
Enrollment
22
Locations
1
Primary Endpoint
Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors
Status
Completed
Last Updated
5 years ago

Overview

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 Description

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.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
December 2010
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Magdeburg
Responsible Party
Principal Investigator
Principal Investigator

Bernhard A. Sabel

Study leader

University of Magdeburg

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors

Time Frame: Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at 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.

Secondary Outcomes

  • Other Visual and EEG Parameters(Nov 2006 - Dec 2010)

Study Sites (1)

Loading locations...

Similar Trials