Trial of Alternating Current Stimulation in Optic Neuropathy

Optic Nerve Diseases Clinical Trial

— SCT_optnerve  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270126
• Other study ID #: EBS_optnerve_SCT
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Est. completion date: December 2010

Study information

• Verified date: December 2013
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Optic Nerve Diseases
• Optic Nerve Injuries
• Optic Neuropathies
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
Germany	Institute of Medical Psychology	Magdeburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Magdeburg	EBS Technologies GmbH

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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