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Enhance of Language Learning With Neurostimulation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00854893
First Posted: March 3, 2009
Last Update Posted: August 3, 2017
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:
German Research Foundation
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
  Purpose
The purpose of this study is to test the effect of transcranial direct current stimulation over the motor cortex of the language dominant hemisphere on language learning in healthy subjects and stroke patients with aphasia. We hypothesize that anodal stimulation enhances the learning of action words compared to sham and cathodal stimulation.

Condition Intervention
Stroke Aphasia Aging Device: transcranial direct current stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhance of Language Learning With Neurostimulation (Transcranial Direct Current Stimulation)

Resource links provided by NLM:


Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • learning of new action words measured as learned words/all words in % [ Time Frame: immediately after intervention and after 1 week ]

Enrollment: 70
Actual Study Start Date: October 2009
Study Completion Date: July 1, 2010
Primary Completion Date: January 1, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anodal
anodal stimulation: 20 min during language learning, intensity: 1 mV, anodal electrode over primary motor cortex of language-dominant hemisphere, reference electrode over contralateral supraorbital area
Device: transcranial direct current stimulation
1 mV for 20 min (verum conditions: anodal and cathodal)or 30 seconds (placebo condition: sham) during language learning , active electrode over primary motor cortex of language dominant hemisphere, reference electrode over contralateral supraorbital area
Other Names:
  • DC Stimulator
  • Manufacturer:eldith -Electro-Diagnostic & Therapeutic Systems GmbH, Gustav-Kirchhoff-Straße 5, D-98693 Ilmenau
  • Serial number: 0006
Experimental: cathodal
anodal stimulation: 20 min during language learning, intensity: 1 mV, cathodal electrode over primary motor cortex of language-dominant hemisphere, reference electrode over contralateral supraorbital area
Device: transcranial direct current stimulation
1 mV for 20 min (verum conditions: anodal and cathodal)or 30 seconds (placebo condition: sham) during language learning , active electrode over primary motor cortex of language dominant hemisphere, reference electrode over contralateral supraorbital area
Other Names:
  • DC Stimulator
  • Manufacturer:eldith -Electro-Diagnostic & Therapeutic Systems GmbH, Gustav-Kirchhoff-Straße 5, D-98693 Ilmenau
  • Serial number: 0006
Experimental: sham (placebo)
sham stimulation (placebo condition): 30 seconds during language learning, intensity: 1 mV, anodal electrode over primary motor cortex of language-dominant hemisphere, reference electrode over contralateral supraorbital area
Device: transcranial direct current stimulation
1 mV for 20 min (verum conditions: anodal and cathodal)or 30 seconds (placebo condition: sham) during language learning , active electrode over primary motor cortex of language dominant hemisphere, reference electrode over contralateral supraorbital area
Other Names:
  • DC Stimulator
  • Manufacturer:eldith -Electro-Diagnostic & Therapeutic Systems GmbH, Gustav-Kirchhoff-Straße 5, D-98693 Ilmenau
  • Serial number: 0006

Detailed Description:
The motor cortex is involved at different levels of language processing. It has been demonstrated that the perception of action words activates motor representations in the language-dominant hemisphere. However, it is not known whether modulation of excitability has an effect on learning new action words. Thus, we hypothesize that transcranial direct current stimulation over the motor cortex of the language-dominant hemiphere modulates the acquisition of new action words. The results bear the potential to design new rehabilitative strategies in stroke patients with aphasia. The motor cortex might offer an access to the language network that can be used for interventional approaches such as neurostimulation.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 86 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age >18 and < 86 years
  • contractual capability
  • ischemic stroke excluding motor cortex (stroke patients)
  • minimum time since stroke 9 months
  • aphasia (stroke patients)
  • severe aphasia that impedes understanding of instructions (stroke patients)

Exclusion Criteria:

  • sever head trauma in the past
  • seizures
  • pace maker
  • metal implants in the head/neck region
  • severe comorbidity, especially neurologic and psychiatric diseases
  • intake of illegal drugs
  • Mini Mental State examination score < 27
  • neuroactive substances, e.g. antidepressants
  • pregnancy
  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): NCT00854893


Locations
Germany
University Hospital Hamburg-Eppendorf, Department of Neurology
Hamburg, HH, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Research Foundation
Investigators
Principal Investigator: Gianpiero Liuzzi, MD Universitätskrankenhaus Hamburg-Eppendorf
  More Information

Additional Information:
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00854893     History of Changes
Other Study ID Numbers: PV3128
Grant # DFG: LI 1892/1-1
First Submitted: March 2, 2009
First Posted: March 3, 2009
Last Update Posted: August 3, 2017
Last Verified: August 2017

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
stroke
aphasia
aging
language learning

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


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