N/A
N=22
Trial of Alternating Current Stimulation in Optic Neuropathy
Optic Nerve Diseases · Optic Nerve Injuries · Optic Neuropathies
Bottom Line
View on ClinicalTrials.gov: NCT01270126 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors — 24.75; 39.16 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Repetitive transorbital alternating current stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Magdeburg
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors |
24.75; 39.16 | — |
| SECONDARY Other Visual and EEG Parameters |
— | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01270126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.