Paraorbital-Occipital Alternating Current Stimulation Therapy for Optic Neuropathy (MCT_optnerve) - Full Text View

Purpose

Aim is to validate that non-invasive brain stimulation can increase cortical excitability in the visual system. The investigators assess if transcranial alternating current stimulation (tACS) can improve visual field size in patients with optic nerve damage. Hypothesis: tACS would improve visual functions within the defective visual field sectors of the visual field (primary outcome measure).

Condition	Intervention
Optic Nerve Diseases Optic Nerve Injuries Optic Neuropathies	Device: tACS Device: Sham stimulation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Multicenter Study of Paraorbital-Occipital Alternating Current Stimulation Therapy in Patients With Optic Neuropathy

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

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: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course ] [ Designated as safety issue: No ]
Central visual fields assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field are characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors is defined as the primary outcome criterion.

Secondary Outcome Measures:

DA change in percent over baseline regarding the total tested visual field (computer-based high-resolution perimetry) [ Time Frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course ] [ Designated as safety issue: No ]
This parameter includes also intact sectors that are tested with HRP. It is hypothesized that improvements of the primary outcome criterion will outweigh the relative change in intact sectors as measured with HRP.
EEG parameters [ Time Frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course ] [ Designated as safety issue: No ]
EEG power spectra
Reaction time change in ms [ Time Frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course ] [ Designated as safety issue: No ]
Reaction time (RT) in HRP
Visual acuity (VA) [ Time Frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course ] [ Designated as safety issue: No ]
DA in static and kinetic conventional perimetry [ Time Frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	December 2010
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Verum stimulation Complete treatment with transorbital alternating current stimulation (tACS)	Device: tACS Transorbital alternating current stimulation (tACS) is applied with a multi-channel device with paraorbital montage of 4 stimulation electrodes generating weak current pulses in predetermined firing bursts of 8 to 14 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.
Sham Comparator: Sham stimulation Same electrode montage set-up is used during tACS- and placebo-stimulation. Sham stimulation condition consists of minimal treatment with low intensity/few impulses tACS.	Device: Sham stimulation tACS is applied with the same device with equal electrodes set-up procedures but only one of four channels actually delivers current. The current intensity of this channel is individually adjusted (preselected on the side of lesioned eye) according with patient able to clearly perceive single phosphenes or any skin irritation phenomena (like weak sense of needles or vibration) whenever a single pulse is applied. The amplitude of pulses is always below 1000 microA. Current pulses are given as 1 pulse per minute during 25-35 min of session time. Session duration is equal for verum and sham patients. The perception of the single pulses leaves sham patients at the impression that they might receive the verum intervention, but total number of pulses is less than 0,5% of verum tACS.

Arms

Assigned Interventions

Experimental: Verum stimulation

Complete treatment with transorbital alternating current stimulation (tACS)

Device: tACS

Transorbital alternating current stimulation (tACS) is applied with a multi-channel device with paraorbital montage of 4 stimulation electrodes generating weak current pulses in predetermined firing bursts of 8 to 14 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.

Sham Comparator: Sham stimulation

Same electrode montage set-up is used during tACS- and placebo-stimulation. Sham stimulation condition consists of minimal treatment with low intensity/few impulses tACS.

Device: Sham stimulation

tACS is applied with the same device with equal electrodes set-up procedures but only one of four channels actually delivers current. The current intensity of this channel is individually adjusted (preselected on the side of lesioned eye) according with patient able to clearly perceive single phosphenes or any skin irritation phenomena (like weak sense of needles or vibration) whenever a single pulse is applied. The amplitude of pulses is always below 1000 microA. Current pulses are given as 1 pulse per minute during 25-35 min of session time. Session duration is equal for verum and sham patients. The perception of the single pulses leaves sham patients at the impression that they might receive the verum intervention, but total number of pulses is less than 0,5% of verum tACS.

Detailed Description:

In addition, the correlation between the brain-derived neurotrophic factor (BDNF) or other plasticity markers are correlated to the improvement of the visual field after stimulation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients with optic nerve lesion
stable visual field defect with residual vision
lesion age at least 6 months
age at least 18 years
no completely blindness, residual vision still existent

Exclusion Criteria:

electric or electronic implants, e.g. heart pacemaker
any metal artefacts in head and truncus
epilepsy
auto-immune diseases in acute stage
mental diseases, e.g. schizophrenia etc.
unstable diabetes, diabetes causing diabetic retinopathy
addiction
high blood pressure (max. 160/100 mmHg)
instable or high level of intraocular pressure (i.e. > 27 mmHg)
retinitis pigmentosa
pathological nystagmus
presence of an un-operated tumor anywhere in the body
pregnant or breast-feeding women
photo sensibility
Fundus hypertonicus
acute conjunctivitis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280877

Locations

Germany
Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin
Berlin, Germany, 10117
Klinische Neurophysiologie & Abteilung Augenheilkunde, Universitätsmedizin Göttingen
Göttingen, Germany, 37075
Augenklinik Kassel am Klinikum Kassel GmbH
Kassel, Germany, 34125
Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg
Magdeburg, Germany, 39120

Sponsors and Collaborators

University of Magdeburg

EBS Technologies GmbH

Investigators

Principal Investigator:

Bernhard A Sabel, Prof. Dr.

Direktor Institut für Medizinische Psychologie, Leipziger Str. 44, D-39120 Magdeburg, Germany

More Information

No publications provided

Responsible Party:	Dr. Ephrat Lahmer-Naim, Clinical Trials Manager, EBS Technologies GmbH, Heinrich-Hertz-Straße 4, D-14532 Kleinmachnow, Germany
ClinicalTrials.gov Identifier:	NCT01280877 History of Changes
Other Study ID Numbers:	EBS-PP-2010-08-10-001
Study First Received:	January 19, 2011
Last Updated:	March 29, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Magdeburg:

optic neuropathy
visual field
electric stimulation
alternating current
perimetry

Additional relevant MeSH terms:

Optic Nerve Diseases
Optic Nerve Injuries
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases

Cranial Nerve Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 16, 2013