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Enhance of Language Learning With Neurostimulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00854893
First received: March 2, 2009
Last updated: March 18, 2011
Last verified: March 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhance of Language Learning With Neurostimulation (Transcranial Direct Current Stimulation)

Resource links provided by NLM:

MedlinePlus related topics: Aphasia
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: October 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (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

Ages Eligible for Study:   18 Years to 86 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854893

Contacts
Contact: Gianpiero Liuzzi, MD +49 40 7410 ext 59278 g.liuzzi@uke.de
Contact: Friedhelm Hummel, MD +49 7410 ext 53772 f.hummel@uke.de

Locations
Germany
University Hospital Hamburg-Eppendorf, Department of Neurology Recruiting
Hamburg, HH, Germany, 20246
Contact: Gianpiero Liuzzi, MD     +49 40 7410 ext 59278     g.liuzzi@uke.de    
Contact: Friedhelm C Hummel, MD     +49 40 7410 ext 53772     f.hummel@uke.de    
Sub-Investigator: Friedhelm C Hummel, MD            
Principal Investigator: Gianpiero Liuzzi, MD            
Sub-Investigator: Nils Freundlieb, MD            
Sub-Investigator: Julia Hoppe, MD            
Sub-Investigator: Maximo Zimerman, MD            
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Research Foundation
Investigators
Principal Investigator: Gianpiero Liuzzi, MD Universitätskrankenhaus Hamburg-Eppendorf
  More Information

Additional Information:
Homepage Brain Imaging and Neurostimulation Lab, Department of Neurology, University Hospital Hamburg-Eppendorf  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Gianpiero Liuzzi, Universitätskrankenhaus Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00854893     History of Changes
Other Study ID Numbers: PV3128, Grant # DFG: LI 1892/1-1
Study First Received: March 2, 2009
Last Updated: March 18, 2011
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Aphasia
Stroke
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013