An interventional study of Sham iTBS and Sham cTBS in Languages, sponsored by Jean-Marie Annoni. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-22.
Sponsored by Jean-Marie Annoni · Not applicable, Interventional, and Basic science
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.
Jean-Marie Annoni is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
intermittent theta burst stimulation (iTBS) + Sham iTBS
Device: Sham iTBS · Device: intermittent theta burst stimulation (iTBS)
continuous theta burst stimulation (cTBS) + Sham cTBS
Device: Sham cTBS · Device: continuous theta burst stimulation (cTBS)
Placebo stimulation for the iTBS group
Placebo stimulation for the cTBS group
Excitatory theta burst stimulation
inhibitory theta burst stimulation
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.
Time frame: Within 30 minutes after intervention
Nonverbal Switching
Nonverbal Switching: response times
Time frame: Within 30 minutes after intervention
| Milestone | iTBS Group | cTBS Group |
|---|---|---|
| Started | 21 | 20 |
| Completed | 20 | 20 |
| Not completed | 1 | 0 |
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.
| Milliseconds | RTs for PN After Intermittent Theta Burst Stimulation | RTs for PN After Continuous Theta Burst Stimulation | RTs for Picture Naming in L1 | RTs for Picture Naming in L2 | RTs for Picture Naming in the Non-switching Blocks | RTs for Picture Naming in the Switching Blocks |
|---|---|---|---|---|---|---|
| RTs for Picture Naming With the Factors Language (L1, L2) and Block (Switching, Non-Switching) | 1103.32 ± 126 | 1107.26 ± 131 | 1098.82 ± 405 | 1158.91 ± 432 | 1081.14 ± 414 | 1175.24 ± 420 |
Nonverbal Switching: response times
| Milliseconds | Intermittent Theta Burst Stimulation | Continuous Theta Burst Stimulation |
|---|---|---|
| Nonverbal Switching | 772.07 ± 159.28 | 739.32 ± 137.23 |
Collected over 3 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| cTBS | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| iTBS | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Sham iTBS | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| Sham cTBS | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | cTBS | iTBS | Sham iTBS | Sham cTBS |
|---|---|---|---|---|
| NauseaCardiac disorders | 0/20 | 0/20 | 1/21 | 0/20 |
| Age, Continuous(years) | Intermittent Theta Burst Stimulation | Continuous Theta Burst Stimulation | Total |
|---|---|---|---|
| Mean | 22.1 ± 2.7 | 22.8 ± 5.36 | 22.4 ± 4.2 |
| Sex: Female, Male(Participants) | Intermittent Theta Burst Stimulation | Continuous Theta Burst Stimulation | Total |
|---|---|---|---|
| Female | 15 | 16 | 31 |
| Male | 6 | 4 | 10 |
| Race and Ethnicity Not Collected(Participants) | Intermittent Theta Burst Stimulation | Continuous Theta Burst Stimulation | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Intermittent Theta Burst Stimulation | Continuous Theta Burst Stimulation | Total |
|---|---|---|---|
| Switzerland | 21 | 20 | 41 |
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Plan to share: No
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Jean-Marie Annoni