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

Not Applicable

Completed

• Conditions: Optic Nerve Diseases; Optic Neuropathies; Optic Nerve Injuries
• Interventions: Device: tACS; Device: Sham stimulation

• Registration Number: NCT01280877
• Lead Sponsor: University of Magdeburg

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-19
• Study First Posted: 2011-01-21
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-27
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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
• epilepsy
• 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
• presence of an un-operated tumor anywhere in the body
• pregnant or breast-feeding women
• photo sensibility
• Fundus hypertonicus
• acute conjunctivitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum stimulation	tACS	Complete treatment with transorbital alternating current stimulation (tACS)
Sham stimulation	Sham stimulation	Same electrode montage set-up is used during tACS- and placebo-stimulation. Sham stimulation condition consists of minimal treatment with low intensity/few impulses tACS.

Primary Outcome Measures

Name	Time	Method
Detection accuracy (DA) change in percent over baseline within defective visual field	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 Outcome Measures

Name	Time	Method
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	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	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	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)	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

Trial Locations

Locations (4)

Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Klinische Neurophysiologie & Abteilung Augenheilkunde, Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

Augenklinik Kassel am Klinikum Kassel GmbH; 🇩🇪 Kassel, Germany

Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg; 🇩🇪 Magdeburg, Germany