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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: University of Magdeburg

Current Primary Outcome: 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.


Original Primary Outcome: Detection accuracy (DA) change in percent over baseline within defective visual field sectors [ 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.


Current Secondary Outcome:

  • 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.
  • 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
  • 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
  • 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 ]
  • 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 ]


Original Secondary Outcome:

  • DA change in percent over baseline regarding the total 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.
  • 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
  • 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
  • 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 ]
  • 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 ]


Information By: University of Magdeburg

Dates:
Date Received: January 19, 2011
Date Started: December 2010
Date Completion:
Last Updated: January 27, 2017
Last Verified: January 2017