Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)

NCT ID: NCT01282827

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-03-31

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

Detailed Description

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exploratory, randomized, controlled study

Conditions

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Visual Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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rtACS (Verum condition)

Repetitive transorbital alternating current stimulation (rtACS)

Group Type EXPERIMENTAL

rtACS (verum condition)

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 1000 microA. 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.

Placebo stimulation

no intervention (Sham stimulation)

Group Type PLACEBO_COMPARATOR

placebo stimulation

Intervention Type DEVICE

a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off).

Interventions

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rtACS (verum condition)

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 1000 microA. 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

placebo stimulation

a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off).

Intervention Type DEVICE

Other Intervention Names

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Device for electrical stimulation "Brainstim" Hersteller: "ELSTIM", St. Petersburg, Russland Device number: "07062006" Classification: Class II, Type BF SLG device marking: "5016-07-P/001" Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig" Device for electrical stimulation "Brainstim" Hersteller: "ELSTIM", St. Petersburg, Russland Device number: "07062006" Classification: Class II, Type BF SLG device marking: "5016-07-P/001" Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"

Eligibility Criteria

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Inclusion Criteria

* residual vision
* patients with optic nerv lesion
* lesion age at least 6 months
* stable visual field defect

Exclusion Criteria

* electric or electronic implants such as pace maker
* any metal artefacts in head and truncus
* epilepsia
* photosensitive epilepsy as determines by EEG
* autoimmune illnesses in acute stage
* mental diseases such e.g. schizophrenia etc.
* diabetes causing diabetic retinopathy
* addiction
* high blood pressure
* unstable or high level intraocular pressure (i.e. \> 27 mmHg)
* retinitis pigmentosa
* pathological nystagmus
* presence of an un-operated tumor or tumor recidive
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Director, Inst Med Psychol

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernhard A Sabel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Magdeburg

Locations

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Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Institut für Medizinische Psychologie, Leipziger Str. 44

Magdeburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EBS-optnerv-BCT

Identifier Type: -

Identifier Source: org_study_id

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