Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)

This study has been completed.
Sponsor:
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
  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:
  • Device for electrical stimulation "Brainstim"
  • Hersteller: "ELSTIM", St. Petersburg, Russland
  • Device number: "07062006"
  • Classification: Class II, Type BF
  • SLG device marking: "5016-07-P/001"
  • Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"
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:
  • Device for electrical stimulation "Brainstim"
  • Hersteller: "ELSTIM", St. Petersburg, Russland
  • Device number: "07062006"
  • Classification: Class II, Type BF
  • SLG device marking: "5016-07-P/001"
  • Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"

  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
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: 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
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 16, 2014