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Clinical Trials/NCT01282827
NCT01282827
Completed
Not Applicable

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

University of Magdeburg2 sites in 1 country40 target enrollmentNovember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Visual Impairment
Sponsor
University of Magdeburg
Enrollment
40
Locations
2
Primary Endpoint
Detection accuracy (DA) change in percent over baseline within defective visual field sectors
Status
Completed
Last Updated
5 years ago

Overview

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

Detailed Description

exploratory, randomized, controlled study

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
March 2010
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Magdeburg
Responsible Party
Principal Investigator
Principal Investigator

Bernhard A. Sabel

Director, Inst Med Psychol

University of Magdeburg

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

  • Visual Parameters 2(baseline to 60 days after stimulation)
  • Visual Parameters 1(baseline to 60 days after stimulation)
  • Visual Parameters 3(baseline to 60 days after stimulation)
  • Visual Parameters 4(baseline to 60 days after stimulation)
  • EEG parameters(baseline to 60 days after stimulation)

Study Sites (2)

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