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Enhance of Language Learning With Neurostimulation

Primary Purpose

Stroke, Aphasia, Aging

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, aphasia, aging, language learning

Eligibility Criteria

18 Years - 86 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Hamburg-Eppendorf, Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

anodal

cathodal

sham (placebo)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

learning of new action words measured as learned words/all words in %

Secondary Outcome Measures

Full Information

First Posted
March 2, 2009
Last Updated
August 27, 2022
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00854893
Brief Title
Enhance of Language Learning With Neurostimulation
Official Title
Enhance of Language Learning With Neurostimulation (Transcranial Direct Current Stimulation)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 2009 (Actual)
Primary Completion Date
January 1, 2010 (Actual)
Study Completion Date
July 1, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia, Aging
Keywords
stroke, aphasia, aging, language learning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
anodal
Arm Type
Experimental
Arm Description
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
Arm Title
cathodal
Arm Type
Experimental
Arm Description
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
Arm Title
sham (placebo)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Other Intervention Name(s)
DC Stimulator, Manufacturer:eldith -Electro-Diagnostic & Therapeutic Systems GmbH, Gustav-Kirchhoff-Straße 5, D-98693 Ilmenau, Serial number: 0006
Intervention Description
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
Primary Outcome Measure Information:
Title
learning of new action words measured as learned words/all words in %
Time Frame
immediately after intervention and after 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianpiero Liuzzi, MD
Organizational Affiliation
Universitätskrankenhaus Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hamburg-Eppendorf, Department of Neurology
City
Hamburg
State/Province
HH
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
28555104
Citation
Branscheidt M, Hoppe J, Freundlieb N, Zwitserlood P, Liuzzi G. tDCS Over the Motor Cortex Shows Differential Effects on Action and Object Words in Associative Word Learning in Healthy Aging. Front Aging Neurosci. 2017 May 15;9:137. doi: 10.3389/fnagi.2017.00137. eCollection 2017.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/20888226
Description
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Enhance of Language Learning With Neurostimulation

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