Study Results
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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UNKNOWN
NA
50 participants
INTERVENTIONAL
2015-04-30
2017-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
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 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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Academy of Finland
OTHER
Helsinki University Central Hospital
OTHER
Responsible Party
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Turgut Tatlisumak, MD, PhD, FAHA, FESO
Associate Professor
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
Countries
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Central Contacts
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Other Identifiers
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UAK1010001
Identifier Type: -
Identifier Source: org_study_id
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