Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)
This study has been completed.
Sponsor:
University of Magdeburg
Collaborator:
Sponsor: EBS Technologier GmbH
Information provided by:
University of Magdeburg
ClinicalTrials.gov Identifier:
NCT01282827
First received: January 21, 2011
Last updated: January 25, 2011
Last verified: January 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Low Vision |
Device: rtACS (verum condition) Device: placebo stimulation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Paraorbital-occipital Alternating Electric Current Stimulation in Patients With Optic Neuropathy |
Further study details as provided by University of Magdeburg:
Primary Outcome Measures:
- Detection accuracy (DA) change in percent over baseline within defective visual field sectors [ Time Frame: between baseline and 60 days after stimulation ] [ Designated as safety issue: No ]Central visus 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).
Secondary Outcome Measures:
- Visual Parameters 1 [ Time Frame: baseline to 60 days after stimulation ] [ Designated as safety issue: No ]DA in static and kinetic perimetry
- Visual Parameters 2 [ Time Frame: baseline to 60 days after stimulation ] [ Designated as safety issue: No ]reaction time (RT) in HRP
- Visual Parameters 3 [ Time Frame: baseline to 60 days after stimulation ] [ Designated as safety issue: No ]visual acuity (VA)
- Visual Parameters 4 [ Time Frame: baseline to 60 days after stimulation ] [ Designated as safety issue: No ]contrast vision
- EEG parameters [ Time Frame: baseline to 60 days after stimulation ] [ Designated as safety issue: No ]EEG power spectra
| Enrollment: | 40 |
| Study Start Date: | November 2006 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: rtACS (Verum condition)
Repetitive transorbital alternating current stimulation (rtACS)
|
Device: 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.
Other Names:
|
|
Placebo Comparator: Placebo stimulation
no intervention (Sham stimulation)
|
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).
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282827
Locations
| Germany | |
| Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin | |
| Berlin, Germany, 10117 | |
| Institut für Medizinische Psychologie, Leipziger Str. 44 | |
| Magdeburg, Germany, 39120 | |
Sponsors and Collaborators
University of Magdeburg
Sponsor: EBS Technologier GmbH
Investigators
| Principal Investigator: | Bernhard A Sabel, Prof. Dr. | University of Magdeburg |
More Information
No publications provided
| Responsible Party: | Prof. Bernhard A. Sabel, University of Magdeburg |
| ClinicalTrials.gov Identifier: | NCT01282827 History of Changes |
| Other Study ID Numbers: | EBS-optnerv-BCT |
| Study First Received: | January 21, 2011 |
| Last Updated: | January 25, 2011 |
| Health Authority: | Germany: Ethics Commission |
Additional relevant MeSH terms:
|
Optic Nerve Diseases Vision, Low Cranial Nerve Diseases Nervous System Diseases Eye Diseases |
Vision Disorders Sensation Disorders Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013