Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions - Tabular View

Tracking Information
First Received Date ^ICMJE	August 16, 2011
Last Updated Date	August 16, 2011
Start Date ^ICMJE	March 2011
Estimated Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 16, 2011)	Detection accuracy change in percent over baseline of the visual field [ Time Frame: between baseline and 60 days after stimulation ] [ Designated as safety issue: No ] visual stimulus detection in residual and absolutely defect field of vision will be assessed using computer-based high resolution perimetry (HRP)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: August 16, 2011)	change in visual stimulus detection rate in the intact field of vision [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ] change in visual stimulus detection rate in the intact field of vision improvement of the acuteness of vision (LogRAD) [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ] improvement of the acuteness of vision (LogRAD) EEG parameters [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ] EEG Power spectra improvement of visual field in conventional perimetry [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ] improvement of visual field in conventional perimetry measured by static perimetry (average threshold in db, average excenticity in degrees) improvement of reaction time [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ] change in average reaction time in ms, measured by HRP
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
Official Title ^ICMJE	Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
Brief Summary	Aim is to validate that non-invasive brain stimulation can increase cortical excitability in the visual system. The investigators hypothesize that the transcranial alternating current stimulation (tACS) can improve the residual field of vision on patients with post-chiasmatic lesions.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Hemianopsia Stroke
Intervention ^ICMJE	Device: Verum Stimulation Paraorbital alternating current stimulation (rtACS) is applied with multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 microA. Current intensity is individually adjusted according to how well patients perceived phosphenes, i.g. any sensation of flickering light in response to the rtACS stimulation. Device: Placebo stimulation clicking sounds, same electrode montage set-up as for verum-arm, but the device delivers no current (stimulator turned off).
Study Arms	Experimental: Verum stimulation Repetitive paraorbital alternating current stimulation (rtACS) Intervention: Device: Verum Stimulation Sham Comparator: Placebo stimulation A clicking sound is presented and the same electrode montage set-up is used during rACS- and Placebo-stimulation, except that placebo patients receive no current (stimulator turned off) Intervention: Device: Placebo stimulation
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	October 2012
Estimated Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 head and truncus Epilepsy Auto-immune diseases in acute stage mental diseases, e.g. schizophrenia etc. diabetes causing diabetic retinopathy addiction high blood pressure (max. 160/100 mmHg) instable or high level of intraocular pressure (>27 mmHg) retinitis pigmentosa pathological nystagmus presence if an un-operated tumor or tumor relapse anywhere in the body focal findings in EEG or photosensitivity recurrent transitional ischemic attacks after stroke atherosclerosis 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 with high risk of cardio-emboly cardiomyopathy ventricular fibrillation risk of vascular thrombosis pregnant or breast-feeding women
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01418820
Other Study ID Numbers ^ICMJE	EBS-PP-2011-02-16-001
Has Data Monitoring Committee	No
Responsible Party	Prof. Bernhard A. Sabel, University of Magdeburg
Study Sponsor ^ICMJE	University of Magdeburg
Collaborators ^ICMJE	Sponsor: EBS Technologies GmbH, Heinrich-Hertz-Str. 4, D-14532 Kleinmachnow, Germany
Investigators ^ICMJE
Information Provided By	University of Magdeburg
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP