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The purpose of this study is to investigate whether theta burst stimulation (TBS) over the left dorsolateral prefrontal cortex (DLPFC) influences language switching and cognitive flexibility. The experimental paradigm will assess the impact of inhibitory and excitatory prefrontal stimulation by TBS versus sham-TBS over the DLPFC in healthy bilinguals.
Background:
Clinical observations and neuroimaging studies seem to confirm the role of executive functions and frontal structures in language processing in bilingual subjects.
Repetitive transcranial magnetic stimulation, such as for example theta burst stimulation (TBS), is increasingly being used as a valuable tool for neuroscientists investigating the underlying mechanisms of cognitive functions. Case studies have shown a change in language switching after bilingual patients received repetitive magnetic stimulation to the left DLPFC. However, there is no study investigating the effect of TBS applied to the DLPFC on language switching in healthy participants.
Procedure:
A planned total of 40 unbalanced bilingual participants will be included. Half of the participants will receive inhibitory theta burst stimulation (continuous TBS), the other half excitatory theta burst stimulation (intermittent TBS). After TBS, different language and nonverbal tasks will be performed while an EEG is measured. Before being stimulated, each subject will conduct the same tasks with a sham-TBS as a baseline measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intermittent theta burst stimulation | Experimental | intermittent theta burst stimulation (iTBS) + Sham iTBS |
|
| continuous theta burst stimulation | Experimental | continuous theta burst stimulation (cTBS) + Sham cTBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham iTBS | Device | Placebo stimulation for the iTBS group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| RTs for Picture Naming With the Factors Language (L1, L2) and Block (Switching, Non-Switching) | Picture naming with the factors Language (L1, L2) and Block (Switching, Non-Switching): Speech onset times (msec) L1 refers to the mother tongue. L2 refers to the late acquired (> age 7) second language. Switching Block refers to a language switching block with picture naming alternated between the mother tongue and the second language. Non-Switching Block refers to a block of picture naming either only in the mother or only in the second language. | Within 30 minutes after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Nonverbal Switching | Nonverbal Switching: response times | Within 30 minutes after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marie Annoni, Prof. Dr. | University of Fribourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laboratory for Cognitive and Neurological Sciences | Fribourg | 1700 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16098377 | Background | Holtzheimer 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. | |
| 25034472 | Background | Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | iTBS Group | intermittent theta burst stimulation (iTBS) + Sham iTBS
|
| FG001 | cTBS Group | continuous theta burst stimulation (cTBS) + Sham cTBS
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intermittent Theta Burst Stimulation | intermittent theta burst stimulation (iTBS) + Sham iTBS Sham iTBS: Placebo stimulation intermittent theta burst stimulation (iTBS): Excitatory rTMS |
| BG001 | Continuous Theta Burst Stimulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | RTs for Picture Naming With the Factors Language (L1, L2) and Block (Switching, Non-Switching) | Picture naming with the factors Language (L1, L2) and Block (Switching, Non-Switching): Speech onset times (msec) L1 refers to the mother tongue. L2 refers to the late acquired (> age 7) second language. Switching Block refers to a language switching block with picture naming alternated between the mother tongue and the second language. Non-Switching Block refers to a block of picture naming either only in the mother or only in the second language. | As a primary outcome we compared RTs following iTBS vs cTBS. Sham-TBS is only used to have a baseline control between the two groups | Posted | Mean | Standard Deviation | Milliseconds | Within 30 minutes after intervention |
|
3 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | cTBS | continuous theta burst stimulation (cTBS) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Jean-Marie Annoni | University of Fribourg | ++4126 306 3802 | jean-marie.annoni@unifr.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2016 | Nov 4, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007802 | Language |
| ID | Term |
|---|---|
| D003142 | Communication |
| D001519 | Behavior |
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| Sham cTBS |
| Device |
Placebo stimulation for the cTBS group |
|
| intermittent theta burst stimulation (iTBS) | Device | Excitatory theta burst stimulation |
|
| continuous theta burst stimulation (cTBS) | Device | inhibitory theta burst stimulation |
|
| 21036201 | Background | Nardone 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. |
continuous theta burst stimulation (cTBS) + Sham cTBS
Sham cTBS: Placebo stimulation
continuous theta burst stimulation (cTBS): inhibitory rTMS
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | RTs for PN After Continuous Theta Burst Stimulation | continuous theta burst stimulation (cTBS) - across switching and non-switching blocks and across L1 and L2. |
| OG002 | RTs for Picture Naming in L1 | Voice onset times for Picture Naming in L1 - across switching and non-switching blocks and across iTBS and cTBS. |
| OG003 | RTs for Picture Naming in L2 | Voice onset times for Picture Naming in L2 - across switching and non-switching blocks and across iTBS and cTBS. |
| OG004 | RTs for Picture Naming in the Non-switching Blocks | Voice onset times for Picture Naming in the non-switching blocks - across L1 and L2 and across iTBS and cTBS. |
| OG005 | RTs for Picture Naming in the Switching Blocks | Voice onset times for Picture Naming in the switching blocks - across L1 and L2 and across iTBS and cTBS. |
|
|
|
| Secondary | Nonverbal Switching | Nonverbal Switching: response times | Data are compared between iTBS and cTBS Sham-TBS is only used to have a baseline control between the two groups | Posted | Mean | Standard Deviation | Milliseconds | Within 30 minutes after intervention |
|
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | iTBS | intermittent theta burst stimulation (iTBS) | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Sham iTBS | Placebo (baseline) stimulation for iTBS group | 0 | 21 | 0 | 21 | 1 | 21 |
| EG003 | Sham cTBS | Placebo (baseline) stimulation for cTBS group | 0 | 20 | 0 | 20 | 0 | 20 |
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