Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia
NCT ID: NCT01277575
Last Updated: 2013-12-19
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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TERMINATED
PHASE3
30 participants
INTERVENTIONAL
2010-12-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Verum stimulation
repetitive transorbital alternating current stimulation (rtACS)
rtACS stimulation (Verum condition)
Repetitive, transorbital alternating current stimulation (rtACS) is applied with multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 microA. Current intensity is individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation
Placebo stimulation
Sham stimulation (placebo condition) no intervention
placebo condition
A clicking sound is presented and the same electrode montage set-up is used during rtASC- and Placebo-stimulation, except that placebo patients received no current (stimulator turned off).
Interventions
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rtACS stimulation (Verum condition)
Repetitive, transorbital alternating current stimulation (rtACS) is applied with multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 microA. Current intensity is individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation
placebo condition
A clicking sound is presented and the same electrode montage set-up is used during rtASC- and Placebo-stimulation, except that placebo patients received no current (stimulator turned off).
Eligibility Criteria
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Inclusion Criteria
* lesion age at least 6 months
* aphasia with at least moderate severity according to Aachener Aphasia Test (AAT)
* age between 40 and 75
* German-speaking (at a native speaking level)
Exclusion Criteria
* intensive language training when exceeding 1 hour, 2 times a week during the 2-weeks stimulation course and the follow-up period (60 days after stimulation was completed)
* additional neurological diseases, e.g. surgical brain tumor removal, untreated tumor disease, acute traumatic brain injury, and/or craniotomy
* (severe) dysarthria
* untreated hypertension exceeding 160/100 mmHg (patients with treated hypertension and blood pressure below 160/100 mmHg can be included)
* increased risk of vascular thrombosis
* epilepsy, photo sensitivity, acute focal findings (patients without focal findings or epileptiform discharges can be included when they had only a single seizure more than 10 years ago)
* dementias and neurodegenerative diseases
* significant psychiatric disturbances, e.g. schizophrenia
* major attention and/or memory deficits
* major hearing loss
* patients with uncorrected visual deficits
* severe global aphasia
* modality-specific disorders (pure speech apraxia, pure alexia, pure agraphia)
* electric or electronic implants (e.g. heart pacemakers)
* metal artefacts located at the head
* medication with impact on the central nervous system (e.g. antidepressant or sedative drugs)
* participation in another trial
* pregnant or breastfeeding women
40 Years
75 Years
ALL
No
Sponsors
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EBS Technologies GmbH
INDUSTRY
University of Magdeburg
OTHER
Responsible Party
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EBS Technologies GmbH
Principal Investigators
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Bernhard A Sabel, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Magdeburg
Locations
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Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30
Aachen, , Germany
Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1
Bernau Waldsiedlung, , Germany
Institut für Medizinische Psychologie, Leipziger Str. 44
Magdeburg, , Germany
Countries
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Other Identifiers
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EBS-PP-2010-08-25-001
Identifier Type: -
Identifier Source: org_study_id