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

This study has been completed.
Sponsor:
Collaborator:
EBS Technologies GmbH
Information provided by:
University of Magdeburg
ClinicalTrials.gov Identifier:
NCT01280877
First received: January 19, 2011
Last updated: March 29, 2012
Last verified: January 2011
  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:


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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Nervous System Diseases
Optic Nerve Diseases
Optic Nerve Injuries
Peripheral Nervous System Diseases
Cranial Nerve Diseases
Cranial Nerve Injuries
Craniocerebral Trauma
Eye Diseases
Neuromuscular Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014