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Restoration of Vision After Stroke (REVIS)

Primary Purpose

Stroke, Infarction; Posterior Cerebral Artery, Hemianopsia

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Active tACS using DC-Stimulator MC
Sham stimulation using DC-Stimulator MC
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Controlled clinical trial, Electric Stimulation Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tACS using DC-Stimulator MC

Sham stimulation using DC-Stimulator MC

Arm Description

15 to 30 patients will be randomized to the arm receiving the active transcranial alternating current stimulation (tACS) treatment using DC-Stimulator MC.

The same number of patients as in the active arm, 15 to 30, will be randomized to receive sham stimulation using DC-Stimulator MC.

Outcomes

Primary Outcome Measures

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

The change in extent of visual fields in standard automated perimetry
A secondary outcome measure will be the change in extent of visual fields i.e. mean threshold measured by means of standard automated perimetry.

Full Information

First Posted
February 6, 2015
Last Updated
March 27, 2015
Sponsor
Helsinki University Central Hospital
Collaborators
Academy of Finland
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1. Study Identification

Unique Protocol Identification Number
NCT02405143
Brief Title
Restoration of Vision After Stroke
Acronym
REVIS
Official Title
Electrical Stimulation for Restoration of Vision After Stroke in the Damaged Visual Field of Patients With Unilateral Stroke (REVIS Helsinki)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
Collaborators
Academy of Finland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Infarction; Posterior Cerebral Artery, Hemianopsia
Keywords
Controlled clinical trial, Electric Stimulation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tACS using DC-Stimulator MC
Arm Type
Experimental
Arm Description
15 to 30 patients will be randomized to the arm receiving the active transcranial alternating current stimulation (tACS) treatment using DC-Stimulator MC.
Arm Title
Sham stimulation using DC-Stimulator MC
Arm Type
Sham Comparator
Arm Description
The same number of patients as in the active arm, 15 to 30, will be randomized to receive sham stimulation using DC-Stimulator MC.
Intervention Type
Device
Intervention Name(s)
Active tACS using DC-Stimulator MC
Intervention Description
Transcranial alternating current stimulation (tACS) is administered using DC-Stimulator MC (NeuroConn GmbH, Ilmenau Germany). Stimulation is administered through two 5 cm2 saline-soaked electrodes placed in the Fpz position and on the right arm. Stimulation will consist of short blocks, during which stimulation frequency will be ramped up to 30Hz with maximum current of 1.5mA. Stimulation will be administered for 20 minutes on 10 consecutive weekdays.
Intervention Type
Device
Intervention Name(s)
Sham stimulation using DC-Stimulator MC
Intervention Description
Patients in the sham group will undergo the same preparations as the treatment group. This includes using an identical electrode placement and session duration as for the experimental arm. In order to create the effect of phosphenes, one 5Hz current burst per minute will be administered using the individual phosphene threshold of the patient. This is not expected to have therapeutic effects.
Primary Outcome Measure Information:
Title
Improved detection in the visual field defined as the percentage change of the stimulus detection rate in High-resolution perimetry (HRP)
Description
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.
Time Frame
Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment
Secondary Outcome Measure Information:
Title
The change in extent of visual fields in standard automated perimetry
Description
A secondary outcome measure will be the change in extent of visual fields i.e. mean threshold measured by means of standard automated perimetry.
Time Frame
Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Turgut Tatlisumak, MD, PhD
Email
turgut.tatlisumak@hus.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Turgut Tatlisumak, MD, PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland

12. IPD Sharing Statement

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Restoration of Vision After Stroke

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