Clinical Trial: Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions

Brief Summary:

Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas.

It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.


Detailed Summary:
Sponsor: University of Magdeburg

Current Primary Outcome: detection accuracy (%) in visual field measures over baseline [ Time Frame: baseline to 8 weeks after stimulation ]

visual stimuli detection accuracy in residual and absolutely defect visual field will be assessed using computer-based high resolution perimetry (HRP)


Original Primary Outcome: Detection accuracy change in percent over baseline of the visual field [ Time Frame: between baseline and 60 days after stimulation ]

visual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)


Current Secondary Outcome:

  • detection accuracy (%) in the intact visual field over baseline [ Time Frame: baseline to 8 weeks after stimulation ]
    visual stimuli detection accuracy in the intact visual field will be assessed using computer-based high resolution perimetry (HRP)
  • visual acuity (LogRAD) [ Time Frame: baseline to 8 weeks after stimulation ]
  • EEG parameters [ Time Frame: baseline to 8 weeks after stimulation ]
    entrainment of stimulation frequencies (EEG power spectra) and measures of functional connectivity
  • conventional perimetry [ Time Frame: baseline to 8 weeks after stimulation ]
    visual fields obtained by static and kinetic perimetry (average threshold in db, average excentricity in degrees)
  • reaction time (ms) [ Time Frame: baseline to 8 weeks after stimulation ]
    average reaction time in ms, measured by computer-based high resolution perimetry (HRP)


Original Secondary Outcome:

  • change in visual stimulus detection rate in the intact field of vision [ Time Frame: baseline to 8 weeks after stimulation ]
    change in visual stimulus detection rate in the intact field of vision
  • improvement of the acuteness of vision (LogRAD) [ Time Frame: baseline to 8 weeks after stimulation ]
    improvement of the acuteness of vision (LogRAD)
  • EEG parameters [ Time Frame: baseline to 8 weeks after stimulation ]
    EEG Power spectra
  • improvement of visual field in conventional perimetry [ Time Frame: baseline to 8 weeks after stimulation ]
    improvement of visual field in conventional perimetry measured by static perimetry (average threshold in db, average excenticity in degrees)
  • improvement of reaction time [ Time Frame: baseline to 8 weeks after stimulation ]
    change in average reaction time in ms, measured by HRP


Information By: University of Magdeburg

Dates:
Date Received: August 16, 2011
Date Started: March 2011
Date Completion: December 2013
Last Updated: November 29, 2013
Last Verified: November 2013