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NCT Number: NCT01282827

Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)

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 with the defective visual field sectors of the visual field (primary outcome measure).

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Key information

Conditions

Visual Impairment Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin, Berlin, Germany

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About this study

exploratory, randomized, controlled study

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • residual vision
  • patients with optic nerv lesion
  • lesion age at least 6 months
  • stable visual field defect

Exclusion criteria

  • electric or electronic implants such as pace maker
  • any metal artefacts in head and truncus
  • epilepsia
  • photosensitive epilepsy as determines by EEG
  • autoimmune illnesses in acute stage
  • mental diseases such e.g. schizophrenia etc.
  • diabetes causing diabetic retinopathy
  • addiction
  • high blood pressure
  • unstable or high level intraocular pressure (i.e. > 27 mmHg)
  • retinitis pigmentosa
  • pathological nystagmus
  • presence of an un-operated tumor or tumor recidive

Treatment and study plan

rtACS (verum condition)

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 1000 microA. 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: Device for electrical stimulation "Brainstim", Hersteller: "ELSTIM", St. Petersburg, Russland, Device number: "07062006", Classification: Class II, Type BF, SLG device marking: "5016-07-P/001", Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"

Placebo stimulation

Device

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

Other names: Device for electrical stimulation "Brainstim", Hersteller: "ELSTIM", St. Petersburg, Russland, Device number: "07062006", Classification: Class II, Type BF, SLG device marking: "5016-07-P/001", Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"

Primary outcomes

  1. Detection accuracy (DA) change in percent over baseline within defective visual field sectors

    Time frame: between baseline and 60 days after stimulation

    Central visus 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).

Secondary outcomes

  1. Visual Parameters 1

    Time frame: baseline to 60 days after stimulation

    DA in static and kinetic perimetry

  2. Visual Parameters 2

    Time frame: baseline to 60 days after stimulation

    reaction time (RT) in HRP

  3. Visual Parameters 3

    Time frame: baseline to 60 days after stimulation

    visual acuity (VA)

  4. Visual Parameters 4

    Time frame: baseline to 60 days after stimulation

    contrast vision

  5. EEG parameters

    Time frame: baseline to 60 days after stimulation

    EEG power spectra

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Collaborators

  • EBS Technologies GmbH

Registry information

Official study title

Paraorbital-occipital Alternating Electric Current Stimulation in Patients With Optic Neuropathy

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 25, 2011
Registry last updated
Jan 15, 2021

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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