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Clinical Trials/NCT02405143
NCT02405143
Unknown
Not Applicable

Electrical Stimulation for Restoration of Vision After Stroke in the Damaged Visual Field of Patients With Unilateral Stroke (REVIS Helsinki)

Helsinki University Central Hospital1 site in 1 country50 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Helsinki University Central Hospital
Enrollment
50
Locations
1
Primary Endpoint
Improved detection in the visual field defined as the percentage change of the stimulus detection rate in High-resolution perimetry (HRP)
Last Updated
11 years ago

Overview

Brief Summary

Occipital stroke is associated with homonymous visual field defects (occurring on one side of the visual field). Despite spontaneous recovery, some degree of defect is often permanent. Currently, no treatment exists for such visual field defects.The purpose of this study is to test the efficacy of a type of electrical brain stimulation method, transcranial alternating current stimulation, in reducing these type of visual field defects in their chronic stage.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
June 2017
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Turgut Tatlisumak, MD, PhD, FAHA, FESO

Associate Professor

Helsinki University Central Hospital

Eligibility Criteria

Inclusion Criteria

  • Occipital ischemic or hemorrhagic stroke 6 months or older
  • Hemianopia or quadrantanopia demonstrated by standard automated perimetry
  • Visual field defect is stable across baseline
  • Presence of residual vision and detectable gradual transition between the the intact and absolutely blind parts of the visual field
  • Best corrected visual acuity for at least one eye better or equal to 0.4

Exclusion Criteria

  • Eye or central nervous system disease that interferes with the study
  • Cardiac pacemaker
  • Other metallic devices or implants precluding participation in MRI scans
  • Pregnancy or lactation period
  • Epileptic seizures in the past 10 years
  • Use of antiepileptic or sedative drugs
  • Expected low compliance due to substance abuse
  • Known active malignancy

Outcomes

Primary Outcomes

Improved detection in the visual field defined as the percentage change of the stimulus detection rate in High-resolution perimetry (HRP)

Time Frame: Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment

HRP is a computer-based perimetry using a supra-threshold stimulus. It is used to detect residual vision between the absolute defect and seeing field and to monitor subtle changes in perceptual ability. HRP is performed in fixation control using an eye tracker. The primary outcome measure will be the percentage change in HRP detection accuracy between pre-test and post-test measurements.

Secondary Outcomes

  • The change in extent of visual fields in standard automated perimetry(Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment)

Study Sites (1)

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