Restoration of Vision After Stroke

Not Applicable

• Conditions: Infarction; Posterior Cerebral Artery; Hemianopsia; Stroke
• Interventions: Device: Sham stimulation using DC-Stimulator MC; Device: Active tACS using DC-Stimulator MC

• Registration Number: NCT02405143
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-06
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-27
• Last Update Submitted: 2015-03-27
• Study Start: 2015-04
• Study First Posted: 2015-04-01
• Last Update Posted: 2015-04-01
• Primary Completion: 2016-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation using DC-Stimulator MC	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.
Active tACS using DC-Stimulator MC	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland