AphasiaNCT02840370
Effect of Stimulation of the Prefrontal Cortex on Language Production in Aphasic Patients
A study testing transcranial direct current stimulation in people with Aphasia, run by Jean-Marie Annoni at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 3 sitesSwitzerland
- Study dates
- May 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Laboratory for Cognitive and Neurological Sciences
Fribourg, 1700
Hôpital Cantonal de Fribourg
Fribourg, 1708
University Hospital Geneva
Geneva, 1206
About this study
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
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).
- Conditions
- Aphasia
- Being tested
- transcranial direct current stimulation, Sham tDCS
- Keywords
- transcranial direct current stimulation, aphasia, language production, prefrontal cortex
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
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 tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| transcranial direct current stimulation | Experimental | tDCS Receives: Device: transcranial direct current stimulation |
| Sham tDCS | Sham comparator | S-tDCS Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language production
Picture naming task, repetition task and verbal fluency task
Measured: up to 30 min
Secondary outcomes (1)
Nonverbal executive functions task
Measured: up to 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean-Marie Annoni
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Hôpital Fribourgeois
- Responsible party
- Sponsor-investigator, Jean-Marie Annoni, University of Fribourg
- Investigators
- Jean-Marie Annoni, Prof. Dr., Principal investigator, University of Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840370
- Sponsor's protocol ID
- SNF325130_156937_3
- Status last verified
- Oct 2017
- First submitted
- 19 Jul 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 23146876Tortella 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 25815258Floel 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 23727025Torres 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 23719561Monti 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02840370
- Acronym / sponsor ID
- SNF325130_156937_3
- Conditions
- Aphasia
- Keywords
- transcranial direct current stimulation, aphasia, language production, prefrontal cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Jean-Marie AnnoniUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Hôpital Fribourgeois
- Study start
- May 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial direct current stimulation | Experimental | Device: transcranial direct current stimulationtDCS |
| Sham tDCS | Sham comparator | Device: Sham tDCSS-tDCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationIn 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. | Device | transcranial direct current stimulation |
| Sham tDCSS-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. | Device | Sham tDCS |
Primary outcome
Language production
Time frame: up to 30 min
Picture naming task, repetition task and verbal fluency task
1 secondary outcome
Nonverbal executive functions task
Time frame: up to 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Background: PubMed 23146876Friederici 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.
- Background: PubMed 25815258Tortella 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.
- Background: PubMed 23727025Floel 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.
- Background: PubMed 23719561Torres 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.
- Background: PubMed 23138766Monti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marie Annoni, Prof. Dr. principal investigator
University of Fribourg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Aphasia, run by Jean-Marie Annoni at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language production (time frame: up to 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02840370, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.