Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with optic nerve lesion
- •stable visual field defect with residual vision
- •lesion age at least 6 months
Exclusion Criteria
- •heart pacemakers and any metal artefacts in head and truncus
- •epileptic seizure within the last 3 years
- •photosensitive epilepsy as determined by EEG
- •mental diseases (schizophrenia etc.)
- •unstable diabetes, diabetes causing diabetic retinopathy
- •macular degeneration, maculopathy with decimal visual acuity below 0.4
- •high blood pressure
- •instable or high level of intraocular pressure (i.e. >27 mmHg)
- •presence of an un-operated tumor anywhere in the body
- •total blindness
- •primary or secondary glaucoma
- •pathological nystagmus
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)
Investigators
Bernhard A. Sabel
Study leader
University of Magdeburg