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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
EBS Technologies GmbH
Information provided by (Responsible Party):
Bernhard A. Sabel, University of Magdeburg
ClinicalTrials.gov Identifier:
NCT01418820
First received: August 16, 2011
Last updated: November 29, 2013
Last verified: November 2013

August 16, 2011
November 29, 2013
March 2011
December 2013   (final data collection date for primary outcome measure)
detection accuracy (%) in visual field measures over baseline [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ]
visual stimuli detection accuracy in residual and absolutely defect visual field will be assessed using computer-based high resolution perimetry (HRP)
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)
Complete list of historical versions of study NCT01418820 on ClinicalTrials.gov Archive Site
  • detection accuracy (%) in the intact visual field over baseline [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ]
    visual stimuli detection accuracy in the intact visual field will be assessed using computer-based high resolution perimetry (HRP)
  • visual acuity (LogRAD) [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ]
  • EEG parameters [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ]
    entrainment of stimulation frequencies (EEG power spectra) and measures of functional connectivity
  • conventional perimetry [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ]
    visual fields obtained by static and kinetic perimetry (average threshold in db, average excentricity in degrees)
  • reaction time (ms) [ Time Frame: baseline to 8 weeks after stimulation ] [ Designated as safety issue: No ]
    average reaction time in ms, measured by computer-based high resolution perimetry (HRP)
  • 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
Not Provided
Not Provided
 
Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Complete Hemianopia
  • Incomplete Hemianopia
  • Scotoma
  • Quadrantanopia
  • Stroke
  • Hemorrhage
  • Brain Trauma
  • Device: Verum stimulation
    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.
  • Device: Placebo stimulation
    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.
  • Experimental: Verum stimulation
    repetitive transorbital alternating current stimulation (rtACS)
    Intervention: Device: Verum stimulation
  • 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
    Intervention: Device: Placebo stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01418820
EBS-PP-2011-02-16-001
No
Bernhard A. Sabel, University of Magdeburg
University of Magdeburg
EBS Technologies GmbH
Principal Investigator: Bernhard A Sabel, Ph.D. Univ. of Magdeburg
University of Magdeburg
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP