Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)

Not Applicable

Completed

• Conditions: Visual Impairment
• Interventions: Device: rtACS (verum condition); Device: placebo stimulation

• Registration Number: NCT01282827
• Lead Sponsor: University of Magdeburg

Brief Summary

Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions with the defective visual field sectors of the visual field (primary outcome measure).

Detailed Description

exploratory, randomized, controlled study

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-13
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• residual vision
• patients with optic nerv lesion
• lesion age at least 6 months
• stable visual field defect

Exclusion Criteria

• electric or electronic implants such as pace maker
• any metal artefacts in head and truncus
• epilepsia
• photosensitive epilepsy as determines by EEG
• autoimmune illnesses in acute stage
• mental diseases such e.g. schizophrenia etc.
• diabetes causing diabetic retinopathy
• addiction
• high blood pressure
• unstable or high level intraocular pressure (i.e. > 27 mmHg)
• retinitis pigmentosa
• pathological nystagmus
• presence of an un-operated tumor or tumor recidive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rtACS (Verum condition)	rtACS (verum condition)	Repetitive transorbital alternating current stimulation (rtACS)
Placebo stimulation	placebo stimulation	no intervention (Sham stimulation)

Primary Outcome Measures

Name	Time	Method
Detection accuracy (DA) change in percent over baseline within defective visual field sectors	between baseline and 60 days after stimulation	Central visus 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).

Secondary Outcome Measures

Name	Time	Method
Visual Parameters 2	baseline to 60 days after stimulation	reaction time (RT) in HRP
Visual Parameters 1	baseline to 60 days after stimulation	DA in static and kinetic perimetry
EEG parameters	baseline to 60 days after stimulation	EEG power spectra
Visual Parameters 3	baseline to 60 days after stimulation	visual acuity (VA)
Visual Parameters 4	baseline to 60 days after stimulation	contrast vision

Trial Locations

Locations (2)

Institut für Medizinische Psychologie, Leipziger Str. 44; 🇩🇪 Magdeburg, Germany

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