- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01418820
Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas.
It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Magdeburg, Germany, 39120
- Inst. f. Medical Psychology, Univ. of Magdeburg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- lesion of the tractus opticus or of the visual cortex
- lesion age > 6 months
- stable visual field defect with residual vision
Exclusion Criteria:
- electric or electronic implants, e.g. heart pacer
- any metal artefacts in the head
- Epilepsy
- Auto-immune diseases in acute stage
- mental diseases, e.g. schizophrenia etc.
- diabetic retinopathy
- addictive diseases
- blood pressure above 160/100 mmHg
- instable or high level of intraocular pressure above 27 mmHg
- retinitis pigmentosa
- pathological nystagmus
- presence of an un-operated tumor or tumor relapse (patients with non-progressive tumor are eligible if study participation is recommended by medical authorities)
- focal findings in EEG or photosensitivity (patients with single seizure more than 10 yrs ago may participate)
- recurrent transitional ischemic attacks after stroke
- arteriosclerosis of large blood vessels with stenosis >75%
- severe coronary heart disease (CHD)
- unstable angina pectoris
- diabetes with blood glucose level > 9 mmol/l
- myocard infarct/ cardiomyopathy
- ventricular fibrillation
- risk of vascular thrombosis
- pregnant or breast-feeding women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Verum stimulation
repetitive transorbital alternating current stimulation (rtACS)
|
10 days (2x 5 working days), daily transorbital alternating current stimulation (rtACS) is applied with a device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses.
The amplitude of each current pulse is below 1000 µA.
Current intensity is individually adjusted according to how well patients perceived phosphenes, e.g.
any sensation of flickering light in response to the rtACS stimulation.
Stimulation frequencies were between the individual alpha frequency peak and below flicker fusion.
|
Sham Comparator: Placebo stimulation
compared to verum stimulation the same electrode montage set-up is used during placebo stimulation, except that placebo patients receive a minimal stimulation
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10 days (2x 5 working days), daily sham-stimulation with the same electrode montage set-up that is used for verum transorbital alternating current stimulation (rtACS).
Minimal sham-stimulation was performed with single bursts (approx.
one per min) of electrical currents at a given frequency of 5Hz and individually adjusted current amplitude.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
detection accuracy (%) in visual field measures over baseline
Time Frame: baseline to 8 weeks after stimulation
|
visual stimuli detection accuracy in residual and absolutely defect visual field will be assessed using computer-based high resolution perimetry (HRP)
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baseline to 8 weeks after stimulation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
detection accuracy (%) in the intact visual field over baseline
Time Frame: baseline to 8 weeks after stimulation
|
visual stimuli detection accuracy in the intact visual field will be assessed using computer-based high resolution perimetry (HRP)
|
baseline to 8 weeks after stimulation
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visual acuity (LogRAD)
Time Frame: baseline to 8 weeks after stimulation
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baseline to 8 weeks after stimulation
|
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EEG parameters
Time Frame: baseline to 8 weeks after stimulation
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entrainment of stimulation frequencies (EEG power spectra) and measures of functional connectivity
|
baseline to 8 weeks after stimulation
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conventional perimetry
Time Frame: baseline to 8 weeks after stimulation
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visual fields obtained by static and kinetic perimetry (average threshold in db, average excentricity in degrees)
|
baseline to 8 weeks after stimulation
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reaction time (ms)
Time Frame: baseline to 8 weeks after stimulation
|
average reaction time in ms, measured by computer-based high resolution perimetry (HRP)
|
baseline to 8 weeks after stimulation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bernhard A Sabel, Ph.D., Univ. of Magdeburg
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Sensation Disorders
- Vision Disorders
- Blindness
- Brain Injuries
- Hemorrhage
- Brain Injuries, Traumatic
- Hemianopsia
- Scotoma
Other Study ID Numbers
- EBS-PP-2011-02-16-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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