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Trial of Alternating Current Stimulation in Optic Neuropathy

NCT ID: NCT01270126

Last Updated: 2020-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Optic Nerve Diseases Optic Nerve Injuries Optic Neuropathies

Keywords

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optic neuropathy alternating current stimulation vision recovery restoration plasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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rtACS (Verum condition)

Repetitive transorbital alternating current stimulation (rtACS)

Group Type EXPERIMENTAL

Repetitive transorbital alternating current stimulation

Intervention Type DEVICE

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.

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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EBS Alpha Synch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EBS Technologies GmbH

INDUSTRY

Sponsor Role collaborator

University of Magdeburg

OTHER

Sponsor Role lead

Responsible Party

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Bernhard A. Sabel

Study leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernhard A Sabel, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Magdeburg

Locations

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Institute of Medical Psychology

Magdeburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type RESULT
PMID: 22124039 (View on PubMed)

Related Links

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http://www.med.uni-magdeburg.de/fme/institute/imp/

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

Other Identifiers

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EBS_optnerve_SCT

Identifier Type: -

Identifier Source: org_study_id