Trial of Alternating Current Stimulation in Optic Neuropathy (SCT_optnerve)

Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial

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 within the defective visual field sectors of the visual field (primary outcome measure).

Study Overview

• Status: Completed
• Conditions: Optic Nerve Diseases; Optic Nerve Injuries; Optic Neuropathies
• Intervention / Treatment: Device: Repetitive transorbital alternating current stimulation

Detailed Description

In a prospective, double-blind, randomized, placebo-controlled clinical trial 22 patients with optic nerve damage were randomly assigned to a rtACS- (n=12) or placebo-group (n=10). Visual field measures, visual acuity and EEG-recordings were collected before and after a daily 20-40min treatment for 10-days and at a 2-months-follow-up. Primary outcome measure was detection accuracy (DA) in defective visual field sectors of computer-based high resolution perimetry (HRP). Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Magdeburg, Germany, 39120
    • Institute of Medical Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

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

Exclusion Criteria

• heart pacemakers and any metal artefacts in head and truncus
• epileptic seizure within the last 3 years
• photosensitive epilepsy as determined by EEG
• mental diseases (schizophrenia etc.)
• unstable diabetes, diabetes causing diabetic retinopathy
• macular degeneration, maculopathy with decimal visual acuity below 0.4
• high blood pressure
• instable or high level of intraocular pressure (i.e. >27 mmHg)
• presence of an un-operated tumor anywhere in the body
• total blindness
• primary or secondary glaucoma
• pathological nystagmus

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rtACS (Verum condition); Repetitive transorbital alternating current stimulation (rtACS)	Device: Repetitive transorbital alternating current stimulation; 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 1000µA. 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: EBS Alpha Synch
No Intervention: Sham stimulation (placebo condition); A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)

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 visual 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). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.	Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Visual and EEG Parameters	Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.	Nov 2006 - Dec 2010

Collaborators and Investigators

• Sponsor: University of Magdeburg
• Collaborators: EBS Technologies GmbH
• Investigators: Principal Investigator: Bernhard A Sabel, PhD, University of Magdeburg

Publications and helpful links

General Publications

• Sabel BA, Fedorov AB, Naue N, Borrmann A, Herrmann C, Gall C. Non-invasive alternating current stimulation improves vision in optic neuropathy. Restor Neurol Neurosci. 2011;29(6):493-505. doi: 10.3233/RNN-2011-0624.

Helpful Links

• Study protocol as submitted (ethical proposal) - link "clinical trials"

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 4, 2011
• First Posted (Estimate): January 5, 2011

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: restoration; plasticity; optic neuropathy; alternating current stimulation; vision recovery
• Additional Relevant MeSH Terms: Eye Diseases; Wounds and Injuries; Neuromuscular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Cranial Nerve Injuries; Peripheral Nervous System Diseases; Nervous System Diseases; Optic Nerve Diseases; Optic Nerve Injuries
• Other Study ID Numbers: EBS_optnerve_SCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided