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Completed

NCT Number: NCT01270126

Trial of Alternating Current Stimulation in Optic Neuropathy

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).

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Key information

Conditions

Optic Nerve Diseases Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Eye Diseases Nervous System Diseases Optic Nerve Injuries Optic Neuropathies Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Medical Psychology

Magdeburg, 39120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transorbital alternating current stimulation

Device

Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.

Other names: EBS Alpha Synch

Primary outcomes

  1. 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

  1. Other Visual and EEG Parameters

    Time frame: Nov 2006 - Dec 2010

    Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Collaborators

  • EBS Technologies GmbH

Registry information

Official study title

Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial

Acronym: SCT_optnerve

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 5, 2011
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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