REVIS: Restoration of Vision After Stroke

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02405143
• Collaborator: Academy of Finland (Other)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Infarction; Posterior Cerebral Artery; Hemianopsia	Device: Active tACS using DC-Stimulator MC; Device: Sham stimulation using DC-Stimulator MC	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Electrical Stimulation for Restoration of Vision After Stroke in the Damaged Visual Field of Patients With Unilateral Stroke (REVIS Helsinki)
• Study Start Date: Apr 1, 2015
• Anticipated Primary Completion Date: Jun 1, 2016
• Anticipated Study Completion Date: Jun 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

1. 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]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Helsinki University Central Hospital	Helsinki		Finland	00290

Sponsors and Collaborators

• Helsinki University Central Hospital
• Academy of Finland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Turgut Tatlisumak, MD, PhD, FAHA, FESO, Associate Professor, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT02405143
• Other Study ID Numbers: UAK1010001
• First Posted: Apr 1, 2015
• Last Update Posted: Apr 1, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Turgut Tatlisumak, MD, PhD, FAHA, FESO, Associate Professor, Helsinki University Central Hospital: Controlled clinical trial; Electric Stimulation Therapy
• Additional relevant MeSH terms: Stroke; Hemianopsia; Infarction

Study Results

No Results Posted as of Apr 1, 2015