Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
- Conditions
- Incomplete HemianopiaHemorrhageStrokeBrain TraumaComplete HemianopiaScotomaQuadrantanopia
- Interventions
- Device: Verum stimulationDevice: Placebo stimulation
- Registration Number
- NCT01418820
- Lead Sponsor
- University of Magdeburg
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- lesion of the tractus opticus or of the visual cortex
- lesion age > 6 months
- stable visual field defect with residual vision
- electric or electronic implants, e.g. heart pacer
- any metal artefacts in the head
- Epilepsy
- Auto-immune diseases in acute stage
- mental diseases, e.g. schizophrenia etc.
- diabetic retinopathy
- addictive diseases
- blood pressure above 160/100 mmHg
- instable or high level of intraocular pressure above 27 mmHg
- retinitis pigmentosa
- pathological nystagmus
- presence of an un-operated tumor or tumor relapse (patients with non-progressive tumor are eligible if study participation is recommended by medical authorities)
- focal findings in EEG or photosensitivity (patients with single seizure more than 10 yrs ago may participate)
- recurrent transitional ischemic attacks after stroke
- arteriosclerosis of large blood vessels with stenosis >75%
- severe coronary heart disease (CHD)
- unstable angina pectoris
- diabetes with blood glucose level > 9 mmol/l
- myocard infarct/ cardiomyopathy
- ventricular fibrillation
- risk of vascular thrombosis
- pregnant or breast-feeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Verum stimulation Verum stimulation repetitive transorbital alternating current stimulation (rtACS) Placebo stimulation Placebo stimulation compared to verum stimulation the same electrode montage set-up is used during placebo stimulation, except that placebo patients receive a minimal stimulation
- Primary Outcome Measures
Name Time Method detection accuracy (%) in visual field measures over baseline 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)
- Secondary Outcome Measures
Name Time Method reaction time (ms) baseline to 8 weeks after stimulation average reaction time in ms, measured by computer-based high resolution perimetry (HRP)
detection accuracy (%) in the intact visual field over baseline 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)
EEG parameters baseline to 8 weeks after stimulation entrainment of stimulation frequencies (EEG power spectra) and measures of functional connectivity
conventional perimetry baseline to 8 weeks after stimulation visual fields obtained by static and kinetic perimetry (average threshold in db, average excentricity in degrees)
visual acuity (LogRAD) baseline to 8 weeks after stimulation
Trial Locations
- Locations (1)
Inst. f. Medical Psychology, Univ. of Magdeburg
🇩🇪Magdeburg, Germany