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Completed

NCT Number: NCT04008589

Non-invasive Current Stimulation for Restoration of Vision

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 to uncover 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Electrical Stimulation Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Medical Psychology

Magdeburg, 39120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transorbital AC Stimulation

Device

Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day

combination of transcranial direct current stimulaton and rtACS

Device

Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS

Primary outcomes

  1. Size of the visual field

    Time frame: 2 weeks

    Mean threshold in standard static perimetry and and detection accuracy in HRP

Secondary outcomes

  1. Resting EEG power spectra

    Time frame: 2 weeks

    EEG measurement using 128 channel

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Collaborators

  • ERA-NET

Registry information

Official study title

Non-invasive Current Stimulation for Restoration of Vision (REVIS) After Unilateral Occipital Stroke

Important dates

Study start
2014
Primary completion
2016
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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