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Effect of Stimulation of the Prefrontal Cortex on Language Production in Aphasic Patients

Primary Purpose

Aphasia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sham tDCS
Sponsored by
Jean-Marie Annoni
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Aphasia focused on measuring transcranial direct current stimulation, aphasia, language production, prefrontal cortex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic aphasia due to ischemic or haemorrhagic stroke (> 6 months post-stroke)
  • French as dominant language
  • Right-handedness
  • Left hemisphere lesion with intact bilateral PFC

Exclusion Criteria:

  • Diagnosed dementia or psychiatric comorbidity
  • Epileptic seizure within the last 12 months
  • Metallic head implants
  • Pacemaker
  • Inability to understand procedures or insufficient language production abilities
  • pregnancy
  • strong headache on the days of the tDCS sessions
  • consumption of alcohol and/or unprescribed drugs on the days of the tDCS sessions or on the day before

Sites / Locations

  • Laboratory for Cognitive and Neurological Sciences
  • Hôpital Cantonal de Fribourg
  • University Hospital Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

transcranial direct current stimulation

Sham tDCS

Arm Description

tDCS

S-tDCS

Outcomes

Primary Outcome Measures

Language production
Picture naming task, repetition task and verbal fluency task

Secondary Outcome Measures

Nonverbal executive functions task

Full Information

First Posted
July 19, 2016
Last Updated
October 24, 2017
Sponsor
Jean-Marie Annoni
Collaborators
University Hospital, Geneva, Hôpital Cantonal de Fribourg
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1. Study Identification

Unique Protocol Identification Number
NCT02840370
Brief Title
Effect of Stimulation of the Prefrontal Cortex on Language Production in Aphasic Patients
Official Title
Effect of Transcranial Direct Current Stimulation of the Prefrontal Cortex on Language Production in Aphasic Patients: a Multicentre Experimental Study With a Placebo-controlled and Double Blind Crossover Design
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jean-Marie Annoni
Collaborators
University Hospital, Geneva, Hôpital Cantonal de Fribourg

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate whether transcranial direct current stimulation (tDCS) of the prefrontal cortex (PFC) influences lexical access and language production. The experimental paradigm will assess the impact of prefrontal stimulation by tDCS versus sham tDCS (S-tDCS) over the PFC of patients with chronic post-stroke aphasia during three language production tasks and a nonverbal executive functions task.
Detailed Description
Background: Language processing is a complex brain function supported by a large network, including domain-specific language areas as well as domain-general cognitive-control networks (Friederici & Gierhan, 2013). Noninvasive brain stimulation, such as transcranial direct current stimulation (tDCS), is increasingly being used as a promising therapeutic tool for psychiatric and neurological diseases (Tortella et al., 2015; Flöel, 2014). In the language domain, several studies revealed that tDCS over languagespecific areas induces changes in cortical function that enhances the recovery of language abilities in patients with post-stroke aphasia (Torres, Drebing & Hamilton, 2013; Monti et al., 2013). Beneficial effects of tDCS have also been found for stimulation over more domain-general cognitive control regions. Although research on non-invasive brain stimulation and aphasia reveals promising results, studies investigating the modulation of cognitive control-networks on lexical access are rare. Given the importance of a successful interplay between prefrontal and domain-specific language areas, possible therapeutic effects of tDCS over the prefrontal cortex (PFC) in aphasia can be of high value for rehabilitation and basic research. Procedure: A planned total of 30 patients will be included. In a first visit, the severity of aphasia, the medical history as well as inclusion/exclusion criteria will be evaluated. After this visit, patients will undergo two tDCS sessions (one tDCS and one S-tDCS session) with a one week interval between the sessions. Each session consists of an online (during stimulation) and an offline assessment (within 30 minutes after stimulation). Three language tasks and a nonverbal executive function task will be conducted online as well as offline in each of the two sessions (tDCS and S-tDCS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
transcranial direct current stimulation, aphasia, language production, prefrontal cortex

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
transcranial direct current stimulation
Arm Type
Experimental
Arm Description
tDCS
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
S-tDCS
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
In tDCS, the prefrontal cortex is stimulated during 20minutes through a weak constant electric current (1-2 mA) through two electrodes in a non-invasive and painless manner.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
S-tDCS refers to a control condition in which the subject will receive a brief current in the beginning in order to induce a similar sensation on the scalp as in tDCS, and then the stimulator remains off for the rest of the stimulation time.
Primary Outcome Measure Information:
Title
Language production
Description
Picture naming task, repetition task and verbal fluency task
Time Frame
up to 30 min
Secondary Outcome Measure Information:
Title
Nonverbal executive functions task
Time Frame
up to 30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic aphasia due to ischemic or haemorrhagic stroke (> 6 months post-stroke) French as dominant language Right-handedness Left hemisphere lesion with intact bilateral PFC Exclusion Criteria: Diagnosed dementia or psychiatric comorbidity Epileptic seizure within the last 12 months Metallic head implants Pacemaker Inability to understand procedures or insufficient language production abilities pregnancy strong headache on the days of the tDCS sessions consumption of alcohol and/or unprescribed drugs on the days of the tDCS sessions or on the day before
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marie Annoni, Prof. Dr.
Organizational Affiliation
University of Fribourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory for Cognitive and Neurological Sciences
City
Fribourg
ZIP/Postal Code
1700
Country
Switzerland
Facility Name
Hôpital Cantonal de Fribourg
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
University Hospital Geneva
City
Geneva
ZIP/Postal Code
1206
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23146876
Citation
Friederici AD, Gierhan SM. The language network. Curr Opin Neurobiol. 2013 Apr;23(2):250-4. doi: 10.1016/j.conb.2012.10.002. Epub 2012 Nov 9.
Results Reference
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PubMed Identifier
25815258
Citation
Tortella G, Casati R, Aparicio LV, Mantovani A, Senco N, D'Urso G, Brunelin J, Guarienti F, Selingardi PM, Muszkat D, Junior Bde S, Valiengo L, Moffa AH, Simis M, Borrione L, Brunoni AR. Transcranial direct current stimulation in psychiatric disorders. World J Psychiatry. 2015 Mar 22;5(1):88-102. doi: 10.5498/wjp.v5.i1.88.
Results Reference
background
PubMed Identifier
23727025
Citation
Floel A. tDCS-enhanced motor and cognitive function in neurological diseases. Neuroimage. 2014 Jan 15;85 Pt 3:934-47. doi: 10.1016/j.neuroimage.2013.05.098. Epub 2013 May 30.
Results Reference
background
PubMed Identifier
23719561
Citation
Torres J, Drebing D, Hamilton R. TMS and tDCS in post-stroke aphasia: Integrating novel treatment approaches with mechanisms of plasticity. Restor Neurol Neurosci. 2013;31(4):501-15. doi: 10.3233/RNN-130314.
Results Reference
background
PubMed Identifier
23138766
Citation
Monti A, Ferrucci R, Fumagalli M, Mameli F, Cogiamanian F, Ardolino G, Priori A. Transcranial direct current stimulation (tDCS) and language. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):832-42. doi: 10.1136/jnnp-2012-302825. Epub 2012 Nov 8.
Results Reference
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Effect of Stimulation of the Prefrontal Cortex on Language Production in Aphasic Patients

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