LanguageNCT02289521
Effect of Stimulation of Dorsolateral Prefrontal Cortex on Language Control
A study testing Transcranial Direct Current Stimulation in people with Language and Executive Dysfunction, run by University of Fribourg at 1 site in Switzerland.
Trial summary
This study aims to evaluate the effect of stimulation of prefrontal regions on language performance (e.g. word translation and picture naming). During the language tests, cortical activity will be registered using electroencephalography (EEG) which will provide supplementary information about the cerebral processus… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Language, Executive Dysfunction
- 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
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2014to May 2018
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- 18-45 years old
- Right-handed
- French as their mother tongue and intermediate level in English.
Who cannot join
- Presence of unstable medical condition (e.g. active epilepsy with seizure in the last 2 years)
- Developmental problem of language
- Metallic head implants
- Scalp skin lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Executive Function on Language: an Experimental and Clinical Approach With Application to Mother Language and Second Language
This study aims to evaluate the effect of stimulation of prefrontal regions on language performance (e.g. word translation and picture naming).
During the language tests, cortical activity will be registered using electroencephalography (EEG) which will provide supplementary information about the cerebral processus involved in language production and management of two languages in bilingual subjects.
Read the detailed description
Effect of stimulation of dorsolateral prefrontal cortex on language production in healthy bilinguals
Background:
Language relies on two main neurocognitive components; a dedicated language network depending on perisylvian structures, and a domain-general control-executive and working memory system relying on prefrontal, particularly left cingulum and dorso-lateral prefrontal cortex (DLPFC) networks. The executive system is known to participate in language control in bilinguals, but also plays a role in many intra-languages processing, for mother language (L1) and even more in second language production (L2).
Anodal-tDCS appears to improve cognitive functions (e.g. working memory, complex verbal problem-solving, inhibition) in adults. Despite the fact that the contribution of executive function in language processing in monolingual and multilingual speakers is crucial, it has not received considerable attention.
Aim:
This study aims to demonstrate the impact of the modulation of executive functions, particularly subserved by DLPFC, on language production in healthy bilingual. The investigators propose that such impact will be particularly present in L2.
The experimental task will test the impact of prefrontal stimulation by tDCS (Anodal compared to Sham) over left DLPFC of healthy adult bilingual subjects during two tasks relying on lexical strategies: a picture naming task in L1 and L2 and a word translation task. The EEG correlates of these tasks performed following tDCS will be analysed, which allows us to investigate precisely the spatiotemporal brain dynamics underlying the behavioural modifications induced by the modulation of left frontal areas. The hypotheses are:
- A-tDCS-induced left DLPFC activation will increase performance particularly in L2 naming and in the translation task versus baseline performances (sham tDCS).
- A-tDCS is expected to modify the cortical activity related to the language tasks. During naming, EEG analyses will show a main effect of stimulation and an interaction between the factors Language (L1 or L2) and Stimulation (sham, anodal) at the topographic level, showing an effect of prefrontal areas larger in L2 than L1. The latency of the ERP modulation by tDCS in L2 will allow us to target the dynamics and the language planning processes underlying improved naming performance.
Methods:
The experimental task will include healthy L1-L2 unbalanced subjects. The investigators will analyse the influence of the DLPFC stimulation on naming and translation ability using tDCS as well as their EEG correlates in L1 and L2. The prediction is that left prefrontal Anodal-stimulation will increase language performances particularly in L2. EEG analyses will unravel the spatio-temporal dynamics of executive processes involved in the two tasks.
EEG EEG is a direct non-invasive technique for recording of the electrical activity produced by neurons over the scalp with a high temporal resolution. EEG recording is obtained by placing electrodes on the scalp. The event-related potentials will be processed/analysed offline.
tDCS TDCS is an affordable and safe method of brain stimulation which can be broadly used in general population. In tDCS, the cerebral cortex is stimulated through a weak constant electric current (1-2 mA) through two electrodes (35 cm2 and 70cm2, an "active" electrode which targets a special region of brain and a "return" electrode). This weak current can induce focal changes of cortical excitability that lasts beyond the period of stimulation. In general, Anodal stimulation (A-tDCS) is supposed to depolarize neurons leading to an increase in excitability, whereas Cathodal stimulation (C-tDCS) has the opposite effect compared to sham. Sham tDCS (S-tDCS) refers to a control condition in which the subject will receive a brief current but then the stimulator remains off for the rest of the stimulation time. In this way, the individuals receiving the S-tDCS are not aware that they are not receiving prolonged stimulation.The mechanisms of tDCS effect are classified into synaptic (changes by altering the strength of synaptic transmission) and non-synaptic (shifts in resting membrane potential of pre and post-synaptic neurons).
Language proficiency assessment To assess language immersion, participants will be asked for the age of acquisition, how long they lived in a region where French and English language was spoken, the language spoken in family, in childhood, in current daily life, and if the language was acquired in or out of school. In the self-evaluation part, participants will indicate in an analogue scale from 1 to 100% how they estimate their reading, speaking, comprehension and writing skills. Moreover, a sub-test from the computer-based DIALANG language diagnosis system will be used to evaluate reading performance.
Procedure This study consists of two sessions, each one week apart, in a counterbalanced order: 1. Anodal A-tDCS, 2. Sham-tDCS. In both sessions, the same evaluations/tasks will be used.
- A-tDCS intervention: The active anodal electrode is placed over DLPFC and the return electrode over contralateral supraorbital area. A 1.5mA direct current will flows between the electrodes for 20 minutes. To decrease current-induced injuries, at the beginning of stimulation, the current reaches from 0 to 1.5mA through 30 seconds (fade-in), and at the end will decrease from 1.5mA to 0 in 15 seconds (fade-out).
- Sham-tDCS intervention: The parameters mimics the A-tDCS (i.e. electrode placement, fade-in and current intensity), except the duration of the stimulation: the current will reach to 1.5mA in 30 seconds (fade-in) and lasts only for 30 seconds (to give the initial sensation of stimulation) then decreases to 0.
The two language contexts will be presented within each of the two sessions in a counterbalanced order across subjects. At the beginning of each language context session, a short text written in the corresponding language will be showed to the subject in order to activate the language of interest. Participants will be seated in an electrically shielded and sound attenuated booth in front of a LCD screen. Stimulus delivery and response recording are controlled using E-Prime 2.0. The stimuli will be presented in the center of the screen.
Stimuli and tasks Verbal and non-verbal fluency tasks, without EEG recording At minute 15/20 of tDCS, a verbal fluency task in L1 will be done (the subject will be asked to name as many words as he/she can which starts with a certain letter during 1 minute). At 16/20 minutes, a non-verbal fluency task (5 points test, i.e. a sheet of paper with 40 squares of fixed symmetrically arranged points (5 points) will be presented to the participant. The participant will be asked to produce as many different figures as possible with connecting the dots with at least one line connecting two dots during 2 minutes). And at minute 18/20, a verbal fluency in L2 will be done during 1 minute (according to Nitsche and Paulus the effect of tDCS reaches maximum at 4/20 minutes of stimulation).
Naming task in L1 and L2 during EEG measures The naming task will be done based on a corpus of 70 pictures, the corresponding words being matched in English and French on pertinent psycholinguistic factors. The stimuli consist of black and white line drawings (of 8.5 x 8.5cm each) representing manufactured objects (tools, furniture, clothes, kitchen objects, electric apparatus, vehicles etc.) or living objects, selected from the Snodgrass and Vanderwart image bank according to lexical and pre-lexical norms and databases. The naming task consists of 2 blocks, one in L1 and one in L2 (each block with 70 images) with a 2-minute pause between the two blocks. The order of blocks will be counterbalanced. In each trial, an image will be presented centrally (1000 ms) after a fixation cross of 300 ms. The subject then will have maximum 2000 ms to name the object.
Translation task to L1 and L2 during EEG measurement Then, they will performed an offline task consisting in translating during 8 minutes 100 words (5 letters length) from L1 to their second language (L2) or vice versa. Both senses of translation will be mixed randomly to increase working memory load. Translation corpus consists of 50 words in each language, matched across L1 and L2 on frequency, length in syllables and phonemes. Words will be presented on the screen and the subject will be asked to translate each word in the other language. The words will be presented 1500 ms on the screen after a fixation cross of 300ms. The subject will have a maximum 2500ms to do the translation.
Behavioural and EEG analyses Behavioural analysis A first behavioural analysis will compare naming and translation performances, as well as speech onset latencies in both languages.
Statistical analyses will be conducted according to 2X2 experimental designs with Language (L1; L2) and Stimulation (Anodal, Sham) as within-subject factors. The investigators main interest will be the interaction term between Language and Stimulation. The investigators expect the interaction to be driven by the left DLPFC stimulation with A-tDCS improving performance in L2 but not L1.
Event Related Potentials (ERP) analyses ERPs will be analyzed using a step-wise procedure that permits the time-wise, multifactorial statistical assessment of (1) the dynamic changes of scalp-recorded electric field configuration and their temporal segmentation into quasi-stable functional micro-states indexing modulations of the configuration of intracranial generators, (2) global electric field power indexing modulation of response strength of the intracranial generators, (3) intracranial distributed linear electrical source estimations. These analyses will be conducted for each time frame of the whole ERP time-period; however, specific time windows are planned to be sensitive to the investigators factors according to meta-analyses and the investigators previous results: lexical selection is thought to occurs between 170 and 270 ms after picture presentation, so there will be a first time window until 200 ms, a second time window between 200 and 300 ms, and a later time window (300-450 ms) corresponding to lexical-phonological encoding in previous studies. The main effect will be L1 and L2 patterns in term of amplitude, duration and sequences. Then, a second main effect will be the anodal tDCS / sham tDCS effect in an early time window before the vocalization will start. The investigators will expect an interaction between language and stimulation, due to the fact that left DLPFC anodal-tDCS will modulate L2 more than
- Conditions
- Language, Executive Dysfunction
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Transcranial Direct Current stimulation, Executive function, Bilingualism, Dorsolateral Prefrontal Cortex
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
We will use a non-invasive, reversible transcranial direct current stimulation (tDCS) using a low-intensity electrical current. We will use Anodal and Sham tDCS.
- Anodal: Active anodal electrode over F3 (EEG system) and return electrode over right supraorbital area. A 1.5mA current will flow between the electrodes for 20min. To decrease current-induced injuries, at the beginning, the current reaches from 0 to 1.5mA during 30 seconds (fade-in), and decreases from 1.5mA to 0 in 15 seconds at the end (fade-out).
- Sham: The parameters mimics the A-tDCS (i.e. electrode placement, fade-in and current intensity), except the duration of stimulation: the current will reach to 1.5mA in 30 seconds (fade-in) and lasts only for 30 seconds (to give the initial sensation of stimulation).
| Study group | Role | What they receive |
|---|---|---|
| Anodal Transcranial Direct Current Stim. | Active comparator | Transcranial Direct Current Stimulation
Anodal (A-tDCS): Active anodal electrode over F3 (EEG system) and return electrode over right supraorbital area. A 1.5mA current will flow between the electrodes for 20 min. To decrease current-induced injuries, at the beginning the current reaches from 0 to 1.5mA during 30 seconds (fade-in), and decreases from 1.5mA to 0 in 15 seconds at the end (fade-out). Receives: Device: Transcranial Direct Current Stimulation |
| Sham Transcranial Direct Current Stim. | Sham comparator | Transcranial Direct Current Stimulation
Sham: The parameters mimics the A-tDCS (electrode placement, fade-in and current intensity), except the stimulation duration: the current will reach 1.5mA in 30 sec (fade-in) and lasts only for 30 sec (to give the initial sensation of stimulation).
After the stimulation, language performance and EEG will be recorded. Order of interventions (anodal - sham) will be randomised across subjects. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in language performance using behavioural measures
Modifications in language performance using behavioural measures (response reaction time and response accuracy) caused by tDCS.
Measured: Starting October 2014 up to 36 months
Changes in language performance using EEG data
Modifications in language performance using EEG data (e.g. modification in waveforms and topographic maps at 250-300 ms time-window after the presentation of stimuli) caused by tDCS.
Measured: Starting October 2014 up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LanguageStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Fribourg
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bern, University of Geneva, Switzerland
- Responsible party
- Principal investigator, Jean-Marie Annoni, University of Fribourg
- Investigators
- Jean-Marie Annoni, MD, Study director, University of Fribourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289521
- Sponsor's protocol ID
- SNF325130_156937_1
- Status last verified
- Apr 2018
- First submitted
- 8 Oct 2014
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Executive Function on Language: an Experimental and Clinical Approach With Application to Mother Language and Second Language
- ClinicalTrials.gov ID
- NCT02289521
- Acronym / sponsor ID
- SNF325130_156937_1
- Conditions
- Language, Executive Dysfunction
- Keywords
- Transcranial Direct Current stimulation, Executive function, Bilingualism, Dorsolateral Prefrontal Cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of FribourgUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bern, University of Geneva, Switzerland
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 13 Nov 2014 (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.
This study aims to evaluate the effect of stimulation of prefrontal regions on language performance (e.g. word translation and picture naming).
During the language tests, cortical activity will be registered using electroencephalography (EEG) which will provide supplementary information about the cerebral processus involved in language production and management of two languages in bilingual subjects.
Detailed description
Effect of stimulation of dorsolateral prefrontal cortex on language production in healthy bilinguals
Background:
Language relies on two main neurocognitive components; a dedicated language network depending on perisylvian structures, and a domain-general control-executive and working memory system relying on prefrontal, particularly left cingulum and dorso-lateral prefrontal cortex (DLPFC) networks. The executive system is known to participate in language control in bilinguals, but also plays a role in many intra-languages processing, for mother language (L1) and even more in second language production (L2).
Anodal-tDCS appears to improve cognitive functions (e.g. working memory, complex verbal problem-solving, inhibition) in adults. Despite the fact that the contribution of executive function in language processing in monolingual and multilingual speakers is crucial, it has not received considerable attention.
Aim:
This study aims to demonstrate the impact of the modulation of executive functions, particularly subserved by DLPFC, on language production in healthy bilingual. The investigators propose that such impact will be particularly present in L2.
The experimental task will test the impact of prefrontal stimulation by tDCS (Anodal compared to Sham) over left DLPFC of healthy adult bilingual subjects during two tasks relying on lexical strategies: a picture naming task in L1 and L2 and a word translation task. The EEG correlates of these tasks performed following tDCS will be analysed, which allows us to investigate precisely the spatiotemporal brain dynamics underlying the behavioural modifications induced by the modulation of left frontal areas. The hypotheses are:
- A-tDCS-induced left DLPFC activation will increase performance particularly in L2 naming and in the translation task versus baseline performances (sham tDCS).
- A-tDCS is expected to modify the cortical activity related to the language tasks. During naming, EEG analyses will show a main effect of stimulation and an interaction between the factors Language (L1 or L2) and Stimulation (sham, anodal) at the topographic level, showing an effect of prefrontal areas larger in L2 than L1. The latency of the ERP modulation by tDCS in L2 will allow us to target the dynamics and the language planning processes underlying improved naming performance.
Methods:
The experimental task will include healthy L1-L2 unbalanced subjects. The investigators will analyse the influence of the DLPFC stimulation on naming and translation ability using tDCS as well as their EEG correlates in L1 and L2. The prediction is that left prefrontal Anodal-stimulation will increase language performances particularly in L2. EEG analyses will unravel the spatio-temporal dynamics of executive processes involved in the two tasks.
EEG EEG is a direct non-invasive technique for recording of the electrical activity produced by neurons over the scalp with a high temporal resolution. EEG recording is obtained by placing electrodes on the scalp. The event-related potentials will be processed/analysed offline.
tDCS TDCS is an affordable and safe method of brain stimulation which can be broadly used in general population. In tDCS, the cerebral cortex is stimulated through a weak constant electric current (1-2 mA) through two electrodes (35 cm2 and 70cm2, an "active" electrode which targets a special region of brain and a "return" electrode). This weak current can induce focal changes of cortical excitability that lasts beyond the period of stimulation. In general, Anodal stimulation (A-tDCS) is supposed to depolarize neurons leading to an increase in excitability, whereas Cathodal stimulation (C-tDCS) has the opposite effect compared to sham. Sham tDCS (S-tDCS) refers to a control condition in which the subject will receive a brief current but then the stimulator remains off for the rest of the stimulation time. In this way, the individuals receiving the S-tDCS are not aware that they are not receiving prolonged stimulation.The mechanisms of tDCS effect are classified into synaptic (changes by altering the strength of synaptic transmission) and non-synaptic (shifts in resting membrane potential of pre and post-synaptic neurons).
Language proficiency assessment To assess language immersion, participants will be asked for the age of acquisition, how long they lived in a region where French and English language was spoken, the language spoken in family, in childhood, in current daily life, and if the language was acquired in or out of school. In the self-evaluation part, participants will indicate in an analogue scale from 1 to 100% how they estimate their reading, speaking, comprehension and writing skills. Moreover, a sub-test from the computer-based DIALANG language diagnosis system will be used to evaluate reading performance.
Procedure This study consists of two sessions, each one week apart, in a counterbalanced order: 1. Anodal A-tDCS, 2. Sham-tDCS. In both sessions, the same evaluations/tasks will be used.
- A-tDCS intervention: The active anodal electrode is placed over DLPFC and the return electrode over contralateral supraorbital area. A 1.5mA direct current will flows between the electrodes for 20 minutes. To decrease current-induced injuries, at the beginning of stimulation, the current reaches from 0 to 1.5mA through 30 seconds (fade-in), and at the end will decrease from 1.5mA to 0 in 15 seconds (fade-out).
- Sham-tDCS intervention: The parameters mimics the A-tDCS (i.e. electrode placement, fade-in and current intensity), except the duration of the stimulation: the current will reach to 1.5mA in 30 seconds (fade-in) and lasts only for 30 seconds (to give the initial sensation of stimulation) then decreases to 0.
The two language contexts will be presented within each of the two sessions in a counterbalanced order across subjects. At the beginning of each language context session, a short text written in the corresponding language will be showed to the subject in order to activate the language of interest. Participants will be seated in an electrically shielded and sound attenuated booth in front of a LCD screen. Stimulus delivery and response recording are controlled using E-Prime 2.0. The stimuli will be presented in the center of the screen.
Stimuli and tasks Verbal and non-verbal fluency tasks, without EEG recording At minute 15/20 of tDCS, a verbal fluency task in L1 will be done (the subject will be asked to name as many words as he/she can which starts with a certain letter during 1 minute). At 16/20 minutes, a non-verbal fluency task (5 points test, i.e. a sheet of paper with 40 squares of fixed symmetrically arranged points (5 points) will be presented to the participant. The participant will be asked to produce as many different figures as possible with connecting the dots with at least one line connecting two dots during 2 minutes). And at minute 18/20, a verbal fluency in L2 will be done during 1 minute (according to Nitsche and Paulus the effect of tDCS reaches maximum at 4/20 minutes of stimulation).
Naming task in L1 and L2 during EEG measures The naming task will be done based on a corpus of 70 pictures, the corresponding words being matched in English and French on pertinent psycholinguistic factors. The stimuli consist of black and white line drawings (of 8.5 x 8.5cm each) representing manufactured objects (tools, furniture, clothes, kitchen objects, electric apparatus, vehicles etc.) or living objects, selected from the Snodgrass and Vanderwart image bank according to lexical and pre-lexical norms and databases. The naming task consists of 2 blocks, one in L1 and one in L2 (each block with 70 images) with a 2-minute pause between the two blocks. The order of blocks will be counterbalanced. In each trial, an image will be presented centrally (1000 ms) after a fixation cross of 300 ms. The subject then will have maximum 2000 ms to name the object.
Translation task to L1 and L2 during EEG measurement Then, they will performed an offline task consisting in translating during 8 minutes 100 words (5 letters length) from L1 to their second language (L2) or vice versa. Both senses of translation will be mixed randomly to increase working memory load. Translation corpus consists of 50 words in each language, matched across L1 and L2 on frequency, length in syllables and phonemes. Words will be presented on the screen and the subject will be asked to translate each word in the other language. The words will be presented 1500 ms on the screen after a fixation cross of 300ms. The subject will have a maximum 2500ms to do the translation.
Behavioural and EEG analyses Behavioural analysis A first behavioural analysis will compare naming and translation performances, as well as speech onset latencies in both languages.
Statistical analyses will be conducted according to 2X2 experimental designs with Language (L1; L2) and Stimulation (Anodal, Sham) as within-subject factors. The investigators main interest will be the interaction term between Language and Stimulation. The investigators expect the interaction to be driven by the left DLPFC stimulation with A-tDCS improving performance in L2 but not L1.
Event Related Potentials (ERP) analyses ERPs will be analyzed using a step-wise procedure that permits the time-wise, multifactorial statistical assessment of (1) the dynamic changes of scalp-recorded electric field configuration and their temporal segmentation into quasi-stable functional micro-states indexing modulations of the configuration of intracranial generators, (2) global electric field power indexing modulation of response strength of the intracranial generators, (3) intracranial distributed linear electrical source estimations. These analyses will be conducted for each time frame of the whole ERP time-period; however, specific time windows are planned to be sensitive to the investigators factors according to meta-analyses and the investigators previous results: lexical selection is thought to occurs between 170 and 270 ms after picture presentation, so there will be a first time window until 200 ms, a second time window between 200 and 300 ms, and a later time window (300-450 ms) corresponding to lexical-phonological encoding in previous studies. The main effect will be L1 and L2 patterns in term of amplitude, duration and sequences. Then, a second main effect will be the anodal tDCS / sham tDCS effect in an early time window before the vocalization will start. The investigators will expect an interaction between language and stimulation, due to the fact that left DLPFC anodal-tDCS will modulate L2 more than
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal Transcranial Direct Current Stim. | Active comparator | Device: Transcranial Direct Current StimulationTranscranial Direct Current Stimulation Anodal (A-tDCS): Active anodal electrode over F3 (EEG system) and return electrode over right supraorbital area. A 1.5mA current will flow between the electrodes for 20 min. To decrease current-induced injuries, at the beginning the current reaches from 0 to 1.5mA during 30 seconds (fade-in), and decreases from 1.5mA to 0 in 15 seconds at the end (fade-out). |
| Sham Transcranial Direct Current Stim. | Sham comparator | Device: Transcranial Direct Current StimulationTranscranial Direct Current Stimulation Sham: The parameters mimics the A-tDCS (electrode placement, fade-in and current intensity), except the stimulation duration: the current will reach 1.5mA in 30 sec (fade-in) and lasts only for 30 sec (to give the initial sensation of stimulation). After the stimulation, language performance and EEG will be recorded. Order of interventions (anodal - sham) will be randomised across subjects. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects
- 18-45 years old
- Right-handed
- French as their mother tongue and intermediate level in English.
Key exclusion criteria (4 listed)
- Presence of unstable medical condition (e.g. active epilepsy with seizure in the last 2 years)
- Developmental problem of language
- Metallic head implants
- Scalp skin lesions
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 StimulationAlso: tDCSWe will use a non-invasive, reversible transcranial direct current stimulation (tDCS) using a low-intensity electrical current. We will use Anodal and Sham tDCS. * Anodal: Active anodal electrode over F3 (EEG system) and return electrode over right supraorbital area. A 1.5mA current will flow between the electrodes for 20min. To decrease current-induced injuries, at the beginning, the current reaches from 0 to 1.5mA during 30 seconds (fade-in), and decreases from 1.5mA to 0 in 15 seconds at the end (fade-out). * Sham: The parameters mimics the A-tDCS (i.e. electrode placement, fade-in and current intensity), except the duration of stimulation: the current will reach to 1.5mA in 30 seconds (fade-in) and lasts only for 30 seconds (to give the initial sensation of stimulation). | Device | Anodal Transcranial Direct Current Stim., Sham Transcranial Direct Current Stim. |
Primary outcome
Changes in language performance using behavioural measures
Time frame: Starting October 2014 up to 36 months
Modifications in language performance using behavioural measures (response reaction time and response accuracy) caused by tDCS.
Changes in language performance using EEG data
Time frame: Starting October 2014 up to 36 months
Modifications in language performance using EEG data (e.g. modification in waveforms and topographic maps at 250-300 ms time-window after the presentation of stimuli) caused by tDCS.
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 1 May 2018.
- Laboratory for cognitive and neurological sciencesLink provided by the sponsor.
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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, MD study director
University of Fribourg
1 site 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 Language and Executive Dysfunction, run by University of Fribourg at 1 site 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 4 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 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Changes in language performance using behavioural measures (time frame: Starting October 2014 up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2018.