Enhance of Language Learning With Neurostimulation - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 2, 2009

Last Updated Date

March 2, 2009

Start Date ^†

May 2009

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Enhance of Language Learning With Neurostimulation

Official Title ^†

Enhance of Language Learning With Neurostimulation (Transcranial Direct Current Stimulation)

Brief Summary

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.

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Condition ^†

Stroke
Aphasia
Aging

Intervention ^†

Device: transcranial direct current stimulation

Study Arms / Comparison Groups

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
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
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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

Estimated Completion Date

December 2011

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 86 Years

Accepts Healthy Volunteers

Yes

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

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00854893

Responsible Party

Dr. Gianpiero Liuzzi, Universitätskrankenhaus Hamburg-Eppendorf

Secondary IDs ^††

Grant # DFG: LI 1892/1-1

Study Sponsor ^†

Universitätsklinikum Hamburg-Eppendorf

Collaborators ^††

German Research Foundation

Investigators ^†

Principal Investigator:

Gianpiero Liuzzi, MD

Universitätskrankenhaus Hamburg-Eppendorf

Information Provided By

Universitätsklinikum Hamburg-Eppendorf

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.