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

Conditions

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

    • HH
      • 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:
  • 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
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
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

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.

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

Other Study ID Numbers

  • PV3128
  • LI 1892/1-1 (Other Grant/Funding Number: Deutsche Forschungsgemeinschaft (DFG))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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