Multicenter Study of Paraorbital-Occipital Alternating Current Stimulation Therapy in Patients With Optic Neuropathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Optic Nerve Diseases
- Sponsor
- University of Magdeburg
- Enrollment
- 90
- Locations
- 4
- Primary Endpoint
- Detection accuracy (DA) change in percent over baseline within defective visual field
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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 Description
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.
Investigators
Bernhard A. Sabel
Principle PI
University of Magdeburg
Eligibility Criteria
Inclusion Criteria
- •patients with optic nerve lesion
- •stable visual field defect with residual vision
- •lesion age at least 6 months
- •age at least 18 years
- •no completely blindness, residual vision still existent
Exclusion Criteria
- •electric or electronic implants, e.g. heart pacemaker
- •any metal artefacts in head and truncus
- •auto-immune diseases in acute stage
- •mental diseases, e.g. schizophrenia etc.
- •unstable diabetes, diabetes causing diabetic retinopathy
- •addiction
- •high blood pressure (max. 160/100 mmHg)
- •instable or high level of intraocular pressure (i.e. \> 27 mmHg)
- •retinitis pigmentosa
- •pathological nystagmus
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- DA change in percent over baseline regarding the damage region of the tested visual field (computer-based high-resolution perimetry)(Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course)
- EEG parameters(Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course)
- Reaction time change in ms(Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course)
- Visual acuity (VA)(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(Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course)