Restoration of Vision After Stroke

NCT ID: NCT02405143

Last Updated: 2015-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Stroke Infarction; Posterior Cerebral Artery Hemianopsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Active tACS using DC-Stimulator MC

Intervention Type DEVICE

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 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.

Group Type SHAM_COMPARATOR

Sham stimulation using DC-Stimulator MC

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academy of Finland

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Turgut Tatlisumak, MD, PhD, FAHA, FESO

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Turgut Tatlisumak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

Central Contacts

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Turgut Tatlisumak, MD, PhD

Role: CONTACT

Other Identifiers

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UAK1010001

Identifier Type: -

Identifier Source: org_study_id

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