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Trial of Alternating Current Stimulation in Optic Neuropathy

Not Applicable
Completed
Conditions
Optic Nerve Injuries
Optic Neuropathies
Optic Nerve Diseases
Interventions
Device: Repetitive transorbital alternating current stimulation
Registration Number
NCT01270126
Lead Sponsor
University of Magdeburg
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
rtACS (Verum condition)Repetitive transorbital alternating current stimulationRepetitive transorbital alternating current stimulation (rtACS)
Primary Outcome Measures
NameTimeMethod
Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field SectorsOutcome 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 Outcome Measures
NameTimeMethod
Other Visual and EEG ParametersNov 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.

Trial Locations

Locations (1)

Institute of Medical Psychology

🇩🇪

Magdeburg, Germany

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