- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00854893
Enhance of Language Learning with Neurostimulation
December 5, 2024 updated by: Universitätsklinikum Hamburg-Eppendorf
Enhance of Language Learning with Neurostimulation (transcranial Direct Current Stimulation)
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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HH
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Hamburg, HH, Germany, 20246
- University Hospital Hamburg-Eppendorf, Department of Neurology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 86 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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:
|
|
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
|
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:
|
|
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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
word learning
Time Frame: immediately after intervention and after 1 week
|
learning of new action words measured as learned words/all words in %
|
immediately after intervention and after 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gianpiero Liuzzi, MD, Universitätskrankenhaus Hamburg-Eppendorf
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
March 2, 2009
First Submitted That Met QC Criteria
March 2, 2009
First Posted (Estimated)
March 3, 2009
Study Record Updates
Last Update Posted (Actual)
December 11, 2024
Last Update Submitted That Met QC Criteria
December 5, 2024
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PV3128
- LI 1892/1-1 (Other Grant/Funding Number: Deutsche Forschungsgemeinschaft (DFG))
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