LanguageNCT02840396
Effect of rTMS of the Dorsolateral Prefrontal Cortex on Language Production in Healthy Participants
A study testing rTMS in people with Language, run by Jean-Marie Annoni at 1 site in Switzerland.
Trial summary
The purpose of this study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) on language production. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Language
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2016to Jul 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- L1 French, knowledge of English as a foreign language
- 18-45 years of age
- Right-handedness
Who cannot join
- epilepsy /family history of epilepsy
- brain surgery, traumatic brain injuries
- cardiac pacemaker, metallic objects in the body
- history of neurological diseases or psychiatric disorders
- drug use (alcohol, psychoactive medication)
- developmental language disorder
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Laboratory for Cognitive and Neurological Sciences
Fribourg, 1700
About this study
Official title: Role of Executive Function in Language: an Experimental and Clinical Approach With Application to Mother Language and Second Language
The purpose of this study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) on language production.
Read the detailed description
Background:
Several studies investigating healthy or clinical populations have shown that (r)TMS applied over the dorsolateral prefrontal cortex (DLPFC) has an effect on language-related processes such as verbal working memory (Osaka et al., 2007), sentence comprehension (Cotelli et al., 2011) and language switching (Holtzheimer et al., 2005, Nardone et al., 2011).
Clinical observations and neuroimaging studies seem to confirm the role of executive functions and frontal structures in language processing in monolingual and bilingual subjects (e.g. Fabbro et al., 2000, Abutalebi \& Green 2007). However, only few studies investigated the effects of modulation of cognitive control-networks on lexical access.
Aim and procedure:
The study will investigate the role of the DLPFC and executive functioning in L1 and L2 language processing. The core question is whether rTMS over the DLPFC will influence lexical access and language production.
Each participant will take part in two sessions: 1. rTMS session 2. Sham rTMS session. After the application of rTMS/Sham rTMS, the participants will conduct two language tasks (translation, picture naming) and a non-verbal task, while the EEG is recorded.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
repetitive TMS (rTMS) can lead to temporary increases or decreases (depending on the protocol used) in excitability of the targeted area. This change in excitability has been shown to last beyond the duration of the stimulation.
Sham rTMSDevice
Sham rTMS (or placebo rTMS) refers to a control condition in which no physiological effect on the targeted cortical region occurs.
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | Not described Receives: Device: rTMS |
| Sham rTMS | Sham comparator | Not described Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language production
Picture naming task and word translation task
Measured: within 30 mins after rTMS/sham rTMS
Secondary outcomes (1)
non-verbal executive functions task
Measured: within 30 mins after rTMS/sham rTMS
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 startMar 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean-Marie Annoni
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- 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
- NCT02840396
- Sponsor's protocol ID
- SNF325130_156937_2
- Status last verified
- Oct 2019
- First submitted
- 19 Jul 2016
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Osaka N, Otsuka Y, Hirose N, Ikeda T, Mima T, Fukuyama H, Osaka M. Transcranial magnetic stimulation (TMS) applied to left dorsolateral prefrontal cortex disrupts verbal working memory performance in humans. Neurosci Lett. 2007 May 18;418(3):232-5. doi: 10.1016/j.neulet.2007.01.087. Epub 2007 Apr 8.
PubMed 17467169Cotelli M, Calabria M, Manenti R, Rosini S, Zanetti O, Cappa SF, Miniussi C. Improved language performance in Alzheimer disease following brain stimulation. J Neurol Neurosurg Psychiatry. 2011 Jul;82(7):794-7. doi: 10.1136/jnnp.2009.197848. Epub 2010 Jun 23.
PubMed 20574108Holtzheimer P, Fawaz W, Wilson C, Avery D. Repetitive transcranial magnetic stimulation may induce language switching in bilingual patients. Brain Lang. 2005 Sep;94(3):274-7. doi: 10.1016/j.bandl.2005.01.003.
PubMed 16098377Nardone R, De Blasi P, Bergmann J, Caleri F, Tezzon F, Ladurner G, Golaszewski S, Trinka E. Theta burst stimulation of dorsolateral prefrontal cortex modulates pathological language switching: A case report. Neurosci Lett. 2011 Jan 10;487(3):378-82. doi: 10.1016/j.neulet.2010.10.060. Epub 2010 Oct 29.
PubMed 21036201Fabbro F, Skrap M, Aglioti S. Pathological switching between languages after frontal lesions in a bilingual patient. J Neurol Neurosurg Psychiatry. 2000 May;68(5):650-2. doi: 10.1136/jnnp.68.5.650.
PubMed 10766900Abutalebi J, Green D. Bilingual language production: The neurocognition of language representation and control. Journal of Neurolinguistics, 20, 242-275, 2007.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Executive Function in Language: an Experimental and Clinical Approach With Application to Mother Language and Second Language
- ClinicalTrials.gov ID
- NCT02840396
- Acronym / sponsor ID
- SNF325130_156937_2
- Conditions
- Language
- Keywords
- language, DLPFC, rTMS, Executive Functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Jean-Marie AnnoniUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Mar 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 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 the effects of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) on language production.
Detailed description
Background:
Several studies investigating healthy or clinical populations have shown that (r)TMS applied over the dorsolateral prefrontal cortex (DLPFC) has an effect on language-related processes such as verbal working memory (Osaka et al., 2007), sentence comprehension (Cotelli et al., 2011) and language switching (Holtzheimer et al., 2005, Nardone et al., 2011).
Clinical observations and neuroimaging studies seem to confirm the role of executive functions and frontal structures in language processing in monolingual and bilingual subjects (e.g. Fabbro et al., 2000, Abutalebi \& Green 2007). However, only few studies investigated the effects of modulation of cognitive control-networks on lexical access.
Aim and procedure:
The study will investigate the role of the DLPFC and executive functioning in L1 and L2 language processing. The core question is whether rTMS over the DLPFC will influence lexical access and language production.
Each participant will take part in two sessions: 1. rTMS session 2. Sham rTMS session. After the application of rTMS/Sham rTMS, the participants will conduct two language tasks (translation, picture naming) and a non-verbal task, while the EEG is recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Device: rTMS |
| Sham rTMS | Sham comparator | Device: Sham rTMS |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- L1 French, knowledge of English as a foreign language
- 18-45 years of age
- Right-handedness
Key exclusion criteria (6 listed)
- epilepsy /family history of epilepsy
- brain surgery, traumatic brain injuries
- cardiac pacemaker, metallic objects in the body
- history of neurological diseases or psychiatric disorders
- drug use (alcohol, psychoactive medication)
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 |
|---|---|---|
| rTMSrepetitive TMS (rTMS) can lead to temporary increases or decreases (depending on the protocol used) in excitability of the targeted area. This change in excitability has been shown to last beyond the duration of the stimulation. | Device | rTMS |
| Sham rTMSSham rTMS (or placebo rTMS) refers to a control condition in which no physiological effect on the targeted cortical region occurs. | Device | Sham rTMS |
Primary outcome
Language production
Time frame: within 30 mins after rTMS/sham rTMS
Picture naming task and word translation task
1 secondary outcome
non-verbal executive functions task
Time frame: within 30 mins after rTMS/sham rTMS
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 9 Oct 2019.
- Background: PubMed 17467169Osaka N, Otsuka Y, Hirose N, Ikeda T, Mima T, Fukuyama H, Osaka M. Transcranial magnetic stimulation (TMS) applied to left dorsolateral prefrontal cortex disrupts verbal working memory performance in humans. Neurosci Lett. 2007 May 18;418(3):232-5. doi: 10.1016/j.neulet.2007.01.087. Epub 2007 Apr 8.
- Background: PubMed 20574108Cotelli M, Calabria M, Manenti R, Rosini S, Zanetti O, Cappa SF, Miniussi C. Improved language performance in Alzheimer disease following brain stimulation. J Neurol Neurosurg Psychiatry. 2011 Jul;82(7):794-7. doi: 10.1136/jnnp.2009.197848. Epub 2010 Jun 23.
- Background: PubMed 16098377Holtzheimer P, Fawaz W, Wilson C, Avery D. Repetitive transcranial magnetic stimulation may induce language switching in bilingual patients. Brain Lang. 2005 Sep;94(3):274-7. doi: 10.1016/j.bandl.2005.01.003.
- Background: PubMed 21036201Nardone R, De Blasi P, Bergmann J, Caleri F, Tezzon F, Ladurner G, Golaszewski S, Trinka E. Theta burst stimulation of dorsolateral prefrontal cortex modulates pathological language switching: A case report. Neurosci Lett. 2011 Jan 10;487(3):378-82. doi: 10.1016/j.neulet.2010.10.060. Epub 2010 Oct 29.
- Background: PubMed 10766900Fabbro F, Skrap M, Aglioti S. Pathological switching between languages after frontal lesions in a bilingual patient. J Neurol Neurosurg Psychiatry. 2000 May;68(5):650-2. doi: 10.1136/jnnp.68.5.650.
- BackgroundAbutalebi J, Green D. Bilingual language production: The neurocognition of language representation and control. Journal of Neurolinguistics, 20, 242-275, 2007.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Language, run by Jean-Marie Annoni 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 3 inclusion and 6 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 9 Oct 2019. 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?
Language production (time frame: within 30 mins after rTMS/sham rTMS). 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 NCT02840396, which also lists 6 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 9 Oct 2019.