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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
EBS Technologies GmbH, Heinrich-Hertz-Str 4, D-14532 Kleinmachnow, Germany
Information provided by (Responsible Party):
Bernhard A. Sabel, University of Magdeburg
ClinicalTrials.gov Identifier:
NCT01418820
First received: August 16, 2011
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hemianopsia
Stroke
 Device: Verum Stimulation
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 Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions

Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum stimulation
Repetitive paraorbital alternating current stimulation (rtACS)
 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.
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)
 Device: Placebo stimulation
clicking sounds, same electrode montage set-up as for verum-arm, but the device delivers no current (stimulator turned off).

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418820

Locations
Germany
Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
EBS Technologies GmbH, Heinrich-Hertz-Str 4, D-14532 Kleinmachnow, Germany
  More Information

No publications provided

Responsible Party: Bernhard A. Sabel, Prof. Dr., University of Magdeburg
ClinicalTrials.gov Identifier: NCT01418820     History of Changes
Other Study ID Numbers: EBS-PP-2011-02-16-001
Study First Received: August 16, 2011
Last Updated: February 15, 2013
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hemianopsia
Stroke
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Blindness
 Eye Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013