Restoration of Vision After Stroke (REVIS)

Helsinki University Central Hospital (HUCH)

Status: Unknown

Conditions: Stroke; Infarction; Posterior Cerebral Artery; Hemianopsia

Treatments: Device: Sham stimulation using DC-Stimulator MC; Device: Active tACS using DC-Stimulator MC

Study type: Interventional

Funder types: Other

Identifiers

NCT02405143

UAK1010001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups

Active tACS using DC-Stimulator MC

Experimental group

Description:

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

Treatment:

Device: Active tACS using DC-Stimulator MC

Sham stimulation using DC-Stimulator MC

Sham Comparator group

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.

Treatment:

Device: Sham stimulation using DC-Stimulator MC