search
Back to results

Trial of Alternating Current Stimulation in Optic Neuropathy (SCT_optnerve)

Primary Purpose

Optic Nerve Diseases, Optic Nerve Injuries, Optic Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Repetitive transorbital alternating current stimulation
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Nerve Diseases focused on measuring optic neuropathy, alternating current stimulation, vision recovery, restoration, plasticity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Medical Psychology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

rtACS (Verum condition)

Sham stimulation (placebo condition)

Arm Description

Repetitive transorbital alternating current stimulation (rtACS)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 3, 2011
Last Updated
November 6, 2020
Sponsor
University of Magdeburg
Collaborators
EBS Technologies GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT01270126
Brief Title
Trial of Alternating Current Stimulation in Optic Neuropathy
Acronym
SCT_optnerve
Official Title
Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Magdeburg
Collaborators
EBS Technologies GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Nerve Diseases, Optic Nerve Injuries, Optic Neuropathies
Keywords
optic neuropathy, alternating current stimulation, vision recovery, restoration, plasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rtACS (Verum condition)
Arm Type
Experimental
Arm Description
Repetitive transorbital alternating current stimulation (rtACS)
Arm Title
Sham stimulation (placebo condition)
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Repetitive transorbital alternating current stimulation
Other Intervention Name(s)
EBS Alpha Synch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors
Description
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.
Time Frame
Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics
Secondary Outcome Measure Information:
Title
Other Visual and EEG Parameters
Description
Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.
Time Frame
Nov 2006 - Dec 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard A Sabel, PhD
Organizational Affiliation
University of Magdeburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Medical Psychology
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22124039
Citation
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.
Results Reference
result
Links:
URL
http://www.med.uni-magdeburg.de/fme/institute/imp/
Description
Study protocol as submitted (ethical proposal) - link "clinical trials"

Learn more about this trial

Trial of Alternating Current Stimulation in Optic Neuropathy

We'll reach out to this number within 24 hrs