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Trial record 83 of 362 for:    "Speech Disorder"

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

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ClinicalTrials.gov Identifier: NCT02840370
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
University Hospital, Geneva
Hôpital Cantonal de Fribourg
Information provided by (Responsible Party):
Jean-Marie Annoni, University of Fribourg

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.

Condition or disease Intervention/treatment Phase
Aphasia Device: transcranial direct current stimulation Device: Sham tDCS Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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 Start Date : May 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: transcranial direct current stimulation
tDCS
Device: transcranial direct current stimulation
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.

Sham Comparator: Sham tDCS
S-tDCS
Device: Sham tDCS
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 Measures :
  1. Language production [ Time Frame: up to 30 min ]
    Picture naming task, repetition task and verbal fluency task


Secondary Outcome Measures :
  1. Nonverbal executive functions task [ Time Frame: up to 30 min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840370


Locations
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Switzerland
Laboratory for Cognitive and Neurological Sciences
Fribourg, Switzerland, 1700
Hôpital Cantonal de Fribourg
Fribourg, Switzerland, 1708
University Hospital Geneva
Geneva, Switzerland, 1206
Sponsors and Collaborators
Jean-Marie Annoni
University Hospital, Geneva
Hôpital Cantonal de Fribourg
Investigators
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Principal Investigator: Jean-Marie Annoni, Prof. Dr. University of Fribourg

Publications:
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Responsible Party: Jean-Marie Annoni, Prof. Dr. med., University of Fribourg
ClinicalTrials.gov Identifier: NCT02840370     History of Changes
Other Study ID Numbers: SNF325130_156937_3
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jean-Marie Annoni, University of Fribourg:
transcranial direct current stimulation
aphasia
language production
prefrontal cortex

Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms