Optic Nerve Diseases Clinical Trial
— SCT_optnerveOfficial title:
Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial
Verified date | December 2013 |
Source | University of Magdeburg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 22 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Institute of Medical Psychology | Magdeburg |
Lead Sponsor | Collaborator |
---|---|
University of Magdeburg | EBS Technologies GmbH |
Germany,
Sabel BA, Fedorov AB, Naue N, Borrmann A, Herrmann C, Gall C. Non-invasive alternating current stimulation improves vision in optic neuropathy. Restor Neurol Neurosci. 2011;29(6):493-505. doi: 10.3233/RNN-2011-0624. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors | 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. | Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics | |
Secondary | Other Visual and EEG Parameters | Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra. | Nov 2006 - Dec 2010 |
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