Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)
NCT ID: NCT01282827
Last Updated: 2021-01-15
Study Results
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2006-11-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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rtACS (Verum condition)
Repetitive transorbital alternating current stimulation (rtACS)
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.
Placebo stimulation
no intervention (Sham stimulation)
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).
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.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients with optic nerv lesion
* lesion age at least 6 months
* stable visual field defect
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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EBS Technologies GmbH
INDUSTRY
University of Magdeburg
OTHER
Responsible Party
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Bernhard A. Sabel
Director, Inst Med Psychol
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
Institut für Medizinische Psychologie, Leipziger Str. 44
Magdeburg, , Germany
Countries
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Other Identifiers
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EBS-optnerv-BCT
Identifier Type: -
Identifier Source: org_study_id
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