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

Paraorbital-occipital Alternating Electric Current Stimulation in Patients With Optic Neuropathy

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).

Study Overview

• Status: Completed
• Conditions: Visual Impairment
• Intervention / Treatment: Device: rtACS (verum condition); Device: placebo stimulation

Detailed Description

exploratory, randomized, controlled study

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin
  • Magdeburg, Germany, 39120
    • Institut für Medizinische Psychologie, Leipziger Str. 44

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rtACS (Verum condition); Repetitive transorbital alternating current stimulation (rtACS)	Device: rtACS (verum condition); 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 1000 microA. 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 Names: Device for electrical stimulation "Brainstim"; Hersteller: "ELSTIM", St. Petersburg, Russland; Device number: "07062006"; Classification: Class II, Type BF; SLG device marking: "5016-07-P/001"; Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"
Placebo Comparator: Placebo stimulation; no intervention (Sham stimulation)	Device: placebo stimulation; a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off).; Other Names: Device for electrical stimulation "Brainstim"; Hersteller: "ELSTIM", St. Petersburg, Russland; Device number: "07062006"; Classification: Class II, Type BF; SLG device marking: "5016-07-P/001"; Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection accuracy (DA) change in percent over baseline within defective visual field sectors	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).	between baseline and 60 days after stimulation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Magdeburg
• Collaborators: EBS Technologies GmbH

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Cranial Nerve Diseases; Sensation Disorders; Optic Nerve Diseases; Vision, Low; Vision Disorders
• Other Study ID Numbers: EBS-optnerv-BCT