Restoration of Vision After Stroke

NCT02405143 | Unknown DMC

• 1 other identifier: UAK1010001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Infarction; Posterior Cerebral Artery; Hemianopsia

Keywords

Controlled clinical trial; Electric Stimulation Therapy

Outcome Measures

Primary Outcomes (1)

• Improved detection in the visual field defined as the percentage change of the stimulus detection rate in High-resolution perimetry (HRP)

  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 Outcomes (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

Study Arms (2)

Active tACS using DC-Stimulator MC

EXPERIMENTAL

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

Sham stimulation using DC-Stimulator MC

SHAM COMPARATOR

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

Interventions

Active tACS using DC-Stimulator MC 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.

Active tACS using DC-Stimulator MC

Sham stimulation using DC-Stimulator MC 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.

Sham stimulation using DC-Stimulator MC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Academy of Finland: collaborator

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00290, Finland

Location

MeSH Terms

Conditions

Stroke; Infarction, Posterior Cerebral Artery; Hemianopsia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Blindness; Eye Diseases; Signs and Symptoms

Study Officials

• Turgut Tatlisumak, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Turgut Tatlisumak, MD, PhD

CONTACT

turgut.tatlisumak@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: April 1, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: April 1, 2015

Record last verified: 2015-03

Locations

FI (1)