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NCT Number: NCT01280877

Paraorbital-Occipital Alternating Current Stimulation Therapy for Optic Neuropathy (MCT_optnerve)

Aim is to validate that non-invasive brain stimulation can increase cortical excitability in the visual system. The investigators assess if transcranial alternating current stimulation (tACS) can improve visual field size in patients with optic nerve damage. Hypothesis: tACS would improve visual functions within the defective 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 and older

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

In addition, the correlation between the brain-derived neurotrophic factor (BDNF) or other plasticity markers are correlated to the improvement of the visual field after stimulation.

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
  • age at least 18 years
  • no completely blindness, residual vision still existent

Exclusion criteria

  • electric or electronic implants, e.g. heart pacemaker
  • any metal artefacts in head and truncus
  • epilepsy
  • auto-immune diseases in acute stage
  • mental diseases, e.g. schizophrenia etc.
  • unstable diabetes, diabetes causing diabetic retinopathy
  • addiction
  • high blood pressure (max. 160/100 mmHg)
  • instable or high level of intraocular pressure (i.e. > 27 mmHg)
  • retinitis pigmentosa
  • pathological nystagmus
  • presence of an un-operated tumor anywhere in the body
  • pregnant or breast-feeding women
  • photo sensibility
  • Fundus hypertonicus
  • acute conjunctivitis

Treatment and study plan

tACS

Device

Transorbital alternating current stimulation (tACS) is applied with a multi-channel device with paraorbital montage of 4 stimulation electrodes generating weak current pulses in predetermined firing bursts of 8 to 14 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.

Sham stimulation

Device

tACS is applied with the same device with equal electrodes set-up procedures but only one of four channels actually delivers current. The current intensity of this channel is individually adjusted (preselected on the side of lesioned eye) according with patient able to clearly perceive single phosphenes or any skin irritation phenomena (like weak sense of needles or vibration) whenever a single pulse is applied. The amplitude of pulses is always below 1000 microA. Current pulses are given as 1 pulse per minute during 25-35 min of session time. Session duration is equal for verum and sham patients. The perception of the single pulses leaves sham patients at the impression that they might receive the verum intervention, but total number of pulses is less than 0,5% of verum tACS.

Primary outcomes

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

    Time frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

    Central visual fields assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field are characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors is defined as the primary outcome criterion.

Secondary outcomes

  1. DA change in percent over baseline regarding the damage region of the tested visual field (computer-based high-resolution perimetry)

    Time frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

    This parameter includes also intact sectors that are tested with HRP. It is hypothesized that improvements of the primary outcome criterion will outweigh the relative change in intact sectors as measured with HRP.

  2. EEG parameters

    Time frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

    EEG power spectra

  3. Reaction time change in ms

    Time frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

    Reaction time (RT) in HRP

  4. Visual acuity (VA)

    Time frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

  5. DA in static and kinetic conventional perimetry

    Time frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Collaborators

  • EBS Technologies GmbH

Registry information

Official study title

Multicenter Study of Paraorbital-Occipital Alternating Current Stimulation Therapy in Patients With Optic Neuropathy

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 21, 2011
Registry last updated
Jan 30, 2017

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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