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Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

This study has been terminated.
(recruitment efforts did not result in a sufficient number of patients)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277575
First Posted: January 17, 2011
Last Update Posted: December 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
EBS Technologies GmbH
Information provided by:
University of Magdeburg
  Purpose
The investigators assess if repetitive, transcranial alternating current stimulation (rtACS) can improve the speaking quality of the aphasic patient as well as other communication skills as naming, repeating and understanding spoken words, reading and writing. Further, it will be assessed if memory and attentiveness deficiencies after 10 days of therapy with brain stimulation are stabilized and remain stable after a training-free period of 60 days.

Condition Intervention Phase
Aphasia Device: rtACS stimulation (Verum condition) Device: placebo condition Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Study of Non-invasive Repetitive Paraorbital Alternating Current Stimulation of the Brain: Therapy for Aphasy

Resource links provided by NLM:


Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • improvement of speaking [ Time Frame: between baseline and 60 days after stimulation ]

    assessed by the following tests:

    • Expressive speaking: ANELT (Amsterdam Nijmegen Everyday Language Test), Aachener Aphasie Test
    • receptive speaking: ANELT (Amsterdam Nijmegen Everyday Language Test), Aachener Aphasie Test


Secondary Outcome Measures:
  • successful stabilization of language [ Time Frame: 60 days after stimulation ]
  • speaking functions 1 - communicative skills [ Time Frame: baseline to 60 days after stimulation ]
    • reading and writing: Aachener Aphasy Test
    • attentiveness: TAP test battery
    • working Memory: Wechsler Memory scale-Revised (WMS-R)
    • emitional state: Vision Analogous Mood Scale (VAMS)

  • speaking functions 2 - spontaneous speech faculty [ Time Frame: baseline to 60 days after stimulation ]
    • reading and writing: Aachener Aphasy Test
    • attentiveness: TAP test battery
    • working Memory: Wechsler Memory scale-Revised (WMS-R)
    • emitional state: Vision Analogous Mood Scale (VAMS)

  • speaking functions 3 - naming [ Time Frame: baseline to 60 days after stimulation ]
    • reading and writing: Aachener Aphasy Test
    • attentiveness: TAP test battery
    • working Memory: Wechsler Memory scale-Revised (WMS-R)
    • emitional state: Vision Analogous Mood Scale (VAMS)

  • speaking functions 4 - repeating [ Time Frame: baseline to 60 days after stimulation ]
    • reading and writing: Aachener Aphasy Test
    • attentiveness: TAP test battery
    • working Memory: Wechsler Memory scale-Revised (WMS-R)
    • emitional state: Vision Analogous Mood Scale (VAMS)

  • speaking functions 5 - understanding [ Time Frame: baseline to 60 days after stimulation ]
    • reading and writing: Aachener Aphasy Test
    • attentiveness: TAP test battery
    • working Memory: Wechsler Memory scale-Revised (WMS-R)
    • emitional state: Vision Analogous Mood Scale (VAMS)


Estimated Enrollment: 30
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum stimulation
repetitive transorbital alternating current stimulation (rtACS)
Device: 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
Sham Comparator: Placebo stimulation
Sham stimulation (placebo condition) no intervention
Device: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stroke
  • 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:

  • cognitive or speech-language therapy during the 2-weeks stimulation course
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277575


Locations
Germany
Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30
Aachen, Germany, 52074
Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1
Bernau Waldsiedlung, Germany, 16321
Institut für Medizinische Psychologie, Leipziger Str. 44
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
EBS Technologies GmbH
Investigators
Principal Investigator: Bernhard A Sabel, Prof. Dr. University of Magdeburg
  More Information

Responsible Party: Dr. Ephrat Lahmer-Naim, Clinical Trials Manager, EBS Technologies GmbH
ClinicalTrials.gov Identifier: NCT01277575     History of Changes
Other Study ID Numbers: EBS-PP-2010-08-25-001
First Submitted: January 14, 2011
First Posted: January 17, 2011
Last Update Posted: December 19, 2013
Last Verified: January 2011

Keywords provided by University of Magdeburg:
stroke
aphasia
language

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms