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Trial of Alternating Current Stimulation in Optic Neuropathy (SCT_optnerve)

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ClinicalTrials.gov Identifier: NCT01270126
Recruitment Status : Completed
First Posted : January 5, 2011
Results First Posted : September 4, 2013
Last Update Posted : September 16, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Optic Nerve Diseases Optic Nerve Injuries Optic Neuropathies Device: Repetitive transorbital alternating current stimulation Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial
Study Start Date : November 2006
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: rtACS (Verum condition)
Repetitive transorbital alternating current stimulation (rtACS)
Device: Repetitive transorbital alternating current stimulation
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 Name: EBS Alpha Synch
No Intervention: Sham stimulation (placebo condition)
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)


Outcome Measures

Primary Outcome Measures :
  1. Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors [ Time Frame: Initial diagnostics (baseline), 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 Outcome Measures :
  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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270126


Locations
Germany
Institute of Medical Psychology
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
EBS Technologies GmbH
Investigators
Principal Investigator: Bernhard A Sabel, PhD University of Magdeburg
More Information

Additional Information:
Publications:
Responsible Party: Bernhard A. Sabel, Study leader, University of Magdeburg
ClinicalTrials.gov Identifier: NCT01270126     History of Changes
Other Study ID Numbers: EBS_optnerve_SCT
First Posted: January 5, 2011    Key Record Dates
Results First Posted: September 4, 2013
Last Update Posted: September 16, 2013
Last Verified: September 2013

Keywords provided by Bernhard A. Sabel, University of Magdeburg:
optic neuropathy
alternating current stimulation
vision recovery
restoration
plasticity

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Optic Nerve Diseases
Nervous System Diseases
Optic Nerve Injuries
Neuromuscular Diseases
Cranial Nerve Diseases
Eye Diseases
Cranial Nerve Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries