Enhance of Language Learning With Neurostimulation - Full Text View

Sponsors and Collaborators:	Universitätsklinikum Hamburg-Eppendorf German Research Foundation
Information provided by:	Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT00854893

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:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
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:	May 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
anodal: Experimental 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
cathodal: Experimental 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
sham (placebo): Experimental 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

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, HH
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:

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

This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:

stroke
aphasia
aging
language learning

Study placed in the following topic categories:

Speech Disorders
Cerebral Infarction
Aphasia
Stroke
Vascular Diseases
Language Disorders
Central Nervous System Diseases

Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Neurologic Manifestations
Neurobehavioral Manifestations
Communication Disorders

Additional relevant MeSH terms:

Speech Disorders
Aphasia
Stroke
Nervous System Diseases
Vascular Diseases
Language Disorders
Central Nervous System Diseases

Brain Diseases
Cerebrovascular Disorders
Signs and Symptoms
Neurologic Manifestations
Cardiovascular Diseases
Neurobehavioral Manifestations
Communication Disorders

ClinicalTrials.gov processed this record on September 11, 2009