Trial of Alternating Current Stimulation in Optic Neuropathy
SCT_optnerve
Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial
1 other identifier
interventional
22
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 3, 2011
CompletedFirst Posted
Study publicly available on registry
January 5, 2011
CompletedResults Posted
Study results publicly available
September 4, 2013
CompletedNovember 9, 2020
December 1, 2013
4.1 years
January 3, 2011
June 19, 2013
November 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Other Visual and EEG Parameters
Nov 2006 - Dec 2010
Study Arms (2)
rtACS (Verum condition)
EXPERIMENTALRepetitive transorbital alternating current stimulation (rtACS)
Sham stimulation (placebo condition)
NO INTERVENTIONA 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)
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients with optic nerve lesion
- stable visual field defect with residual vision
- lesion age at least 6 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Magdeburglead
- EBS Technologies GmbHcollaborator
Study Sites (1)
Institute of Medical Psychology
Magdeburg, 39120, Germany
Related Publications (1)
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.
PMID: 22124039RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Bernhard A. Sabel
- Organization
- Otto-von-Guericke University of Magdeburg, Medical Faculty, Institute of Medical Psychology, Magdeburg, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Bernhard A Sabel, PhD
University of Magdeburg
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study leader
Study Record Dates
First Submitted
January 3, 2011
First Posted
January 5, 2011
Study Start
November 1, 2006
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
November 9, 2020
Results First Posted
September 4, 2013
Record last verified: 2013-12