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CompletedNCT02840370Updated Oct 26, 2017

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

An interventional study of transcranial direct current stimulation and Sham tDCS in Aphasia, sponsored by Jean-Marie Annoni. Completed at 3 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-26.

Sponsored by Jean-Marie Annoni · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Aphasia

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Keywords

  • transcranial direct current stimulation
  • aphasia
  • language production
  • prefrontal cortex
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In context

Aphasia

372 studies on the registry are indexed under Aphasia; 90 are open to participants now.

This study's enrollment of 19 is below the median of 30 across 322 interventional studies indexed under Aphasia.

Browse Aphasia studies →

Lead sponsor

Jean-Marie Annoni is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    transcranial direct current stimulation

    tDCS

    Device: transcranial direct current stimulation

  • Sham comparator
    Sham tDCS

    S-tDCS

    Device: Sham tDCS

Interventions

  • Devicetranscranial 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.

  • DeviceSham 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.

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What researchers measure

Primary outcomes

  1. Language production

    Picture naming task, repetition task and verbal fluency task

    Time frame: up to 30 min

Secondary outcomes

  1. Nonverbal executive functions task

    Time frame: up to 30 min

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Study locations

3 sites
  • Laboratory for Cognitive and Neurological Sciences
    Fribourg, 1700, Switzerland
  • Hôpital Cantonal de Fribourg
    Fribourg, 1708, Switzerland
  • University Hospital Geneva
    Geneva, 1206, Switzerland
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References and documents

Publications

  • 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. PubMed 23146876 ↗
  • 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. PubMed 25815258 ↗
  • 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. PubMed 23727025 ↗
  • 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. PubMed 23719561 ↗
  • 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. PubMed 23138766 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2016, a primary completion of Mar 2017 and a completion of Sep 2017. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2016
First posted
Jul 21, 2016
Start
May 2016
Primary completionActual
Mar 2017
CompletionActual
Sep 2017
Last update
Oct 26, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02840370
Lead sponsor
Jean-Marie Annoni
Collaborators
University Hospital, Geneva, Hôpital Fribourgeois
Responsible party
Jean-Marie Annoni (Prof. Dr. med., University of Fribourg) — Sponsor-investigator
First posted
Jul 21, 2016
Start date
May 2016
Primary completion
Mar 2017
Completion
Sep 2017
Last update
Oct 26, 2017

Study contacts

Jean-Marie Annoni, Prof. Dr.
principal investigator · University of Fribourg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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