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Non-invasive Repetitive Paraorbital Alternating Current Stimulation Therapy for Aphasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Magdeburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sponsor: EBS Technologies GmbH
Information provided by:
University of Magdeburg
ClinicalTrials.gov Identifier:
NCT01277575
First received: January 14, 2011
Last updated: August 18, 2011
Last verified: January 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Aphasia
U.S. FDA Resources

Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • improvement of speaking [ Time Frame: between baseline and 60 days after stimulation ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • speaking functions 1 - communicative skills [ Time Frame: baseline to 60 days after stimulation ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    • 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
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277575

Locations
Germany
Neurologische Klinik, Medizinische Fakultät der RWTH Aachen, Pauwelsstr. 30 Recruiting
Aachen, Germany, 52074
Contact: Jörg B Schulz, Prof. Dr.     0049 (0)24180 ext 89600     jschulz@ukaachen.de    
Principal Investigator: Jörg B Schulz, Prof. Dr.            
Neurologische Klinik, Brandenburg Klinik Bernau, Brandenburgallee 1 Recruiting
Bernau Waldsiedlung, Germany, 16321
Contact: Michael Jöbges, Prof. Dr.     0049 (0)333973 ext 4000     joebges@Brandenburgklinik.de    
Principal Investigator: Michael Jöbges, Prof. Dr.            
Sub-Investigator: Wido Nager, Dr.            
Institut für Medizinische Psychologie, Leipziger Str. 44 Recruiting
Magdeburg, Germany, 39120
Contact: Bernhard A Sabel, Prof. Dr.     0049 (0)3916721 ext 800     bernhard.sabel@med.ovgu.de    
Contact: Carolin Gall, Dr.         carolin.gall@med.ovgu.de    
Principal Investigator: Bernhard A Sabel, Prof. Dr.            
Sub-Investigator: Carolin Gall, Dr.            
Sponsors and Collaborators
University of Magdeburg
Sponsor: EBS Technologies GmbH
Investigators
Principal Investigator: Bernhard A Sabel, Prof. Dr. University of Magdeburg
  More Information

No publications provided

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
Study First Received: January 14, 2011
Last Updated: August 18, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 16, 2013