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
|Condition or disease||Intervention/treatment||Phase|
|Optic Nerve Diseases Optic Nerve Injuries Optic Neuropathies||Device: Repetitive transorbital alternating current stimulation||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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)
- 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.
- 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.
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
|Institute of Medical Psychology|
|Magdeburg, Germany, 39120|
|Principal Investigator:||Bernhard A Sabel, PhD||University of Magdeburg|