Restoration of Vision After Stroke (REVIS)

March 27, 2015 updated by: Turgut Tatlisumak, MD, PhD, FAHA, FESO, Helsinki University Central Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Finland
      • Helsinki, Finland, 00290
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active tACS using DC-Stimulator MC
15 to 30 patients will be randomized to the arm receiving the active transcranial alternating current stimulation (tACS) treatment using DC-Stimulator MC.
Device: Active tACS using DC-Stimulator MC
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.
Sham Comparator: Sham stimulation 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.
Device: Sham stimulation using DC-Stimulator MC
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in extent of visual fields in standard automated perimetry
Time Frame: Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment
A secondary outcome measure will be the change in extent of visual fields i.e. mean threshold measured by means of standard automated perimetry.
Change between 3-7 days pre-treatment, at 3-7 days post-treatment, and at 2 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

Academy of Finland

Investigators

  • Principal Investigator: Turgut Tatlisumak, MD, PhD, Helsinki University Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

February 6, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

April 1, 2015

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 27, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAK1010001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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