Non-invasive Current Stimulation for Restoration of Vision

Overview

The aim of the study is to evaluate effects of current stimulation of the brain on vision parameters, vision-related quality of life, and physiological parameters that allow concluding about the mechanisms of vision restoration. These include EEG-spectra and coherence measures, and visual evoked potentials. The design of stimulation protocols involves an appropriate sham-stimulation condition and sufficient follow-up periods to test whether the effects are stable. This is the first application of non-invasive current stimulation for vision rehabilitation in stroke-related visual field deficits.

Full Title of Study: “Non-invasive Current Stimulation for Restoration of Vision (REVIS) After Unilateral Occipital Stroke”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2019

Interventions

  • Device: repetitive transorbital AC Stimulation
    • Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day
  • Device: combination of transcranial direct current stimulaton and rtACS
    • Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS

Arms, Groups and Cohorts

  • Experimental: rtACS
    • repetitive transorbital ACS
  • Experimental: tDCS/rtACS
    • Sequential tDCS – tACS
  • Sham Comparator: Sham stimulation

Clinical Trial Outcome Measures

Primary Measures

  • Size of the visual field
    • Time Frame: 2 weeks
    • Mean threshold in standard static perimetry and and detection accuracy in HRP

Secondary Measures

  • Resting EEG power spectra
    • Time Frame: 2 weeks
    • EEG measurement using 128 channel

Participating in This Clinical Trial

Inclusion Criteria

  • HH due to ischemic or hemorrhagic stroke
  • age between 18 and 75 years
  • lesion age at least 6 months
  • stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
  • presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
  • best corrected visual acuity at least 0.4 (20/50 Snellen) or better

Exclusion Criteria

  • known active malignancy
  • eye or central nervous system diseases that interfere with the study (including poorly controlled glaucoma)
  • electric or electronic implants (e.g. heart pacemaker)
  • metal artifacts in the eyes or head (with the exception of dental prosthesis or shunts)
  • expected low compliance (e.g. in case of known psychiatric disease, known drug abuse, and dementing syndromes)
  • epileptic seizure within the last 10 years
  • use of antiepileptic or sedative drugs

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Magdeburg
  • Collaborator
    • ERA-NET
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bernhard A. Sabel, Prof. – University of Magdeburg

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