Trial of Alternating Current Stimulation in Optic Neuropathy (SCT_optnerve)

University of Magdeburg

Status: Completed

Conditions: Optic Nerve Diseases; Optic Nerve Injuries; Optic Neuropathies

Treatments: Device: Repetitive transorbital alternating current stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01270126

EBS_optnerve_SCT

Details and patient eligibility

About

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).

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

rtACS (Verum condition)

Experimental group

Description:

Repetitive transorbital alternating current stimulation (rtACS)

Treatment:

Device: Repetitive transorbital alternating current stimulation

Sham stimulation (placebo condition)

No Intervention group

Description:

A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)