Clinical trial NCT01270126: Trial of Alternating Current Stimulation in Optic Neuropathy
Official title: Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optic Nerve Diseases
Optic Nerve Injuries
Optic Neuropathies
Keywords: optic neuropathy
alternating current stimulation
vision recovery
restoration
plasticity
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
Collaborators: name: EBS Technologies GmbH
First posted: 2011-01-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors
timeFrame: Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics
Secondary outcomes:
measure: Other Visual and EEG Parameters
timeFrame: Nov 2006 - Dec 2010
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Institute of Medical Psychology
Study officials:
affiliation: University of Magdeburg
name: Bernhard A Sabel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.