Impact of Theta Burst Stimulation Over the Left Dorsolateral Prefrontal Cortex on Language Switching and Cognitive Flexibility
| Registry | NCT03148470 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, factorial, masking: double, basic science |
| Enrollment | 41 (Actual) |
| Sponsor | Jean-Marie Annoni (Other) |
| Conditions | Languages |
| Interventions | Sham iTBS, Sham cTBS, intermittent theta burst stimulation (iTBS), continuous theta burst stimulation (cTBS) (Device) |
| Dates | start 2016-09-01, primary completion 2018-07-01, completion 2019-07-01, first posted 2017-05-11, last updated 2020-04-22 |
| Locations | 1 site in Switzerland |
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All trials for Languages All trials of Sham iTBS All trials of Sham cTBS
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| intermittent theta burst stimulation | Experimental | Device: Sham iTBS; Device: intermittent theta burst stimulation (iTBS) | intermittent theta burst stimulation (iTBS) + Sham iTBS |
| continuous theta burst stimulation | Experimental | Device: Sham cTBS; Device: continuous theta burst stimulation (cTBS) | continuous theta burst stimulation (cTBS) + Sham cTBS |
Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers
Inclusion Criteria: * L1 (Swiss)German, knowledge of English as a foreign language * 18-45 years of age * right-handedness Exclusion Criteria: * epilepsy / family history of epilepsy * brain surgery, traumatic brain injuries * cardiac pacemaker, metallic objects in the head * history of neurological diseases or severe psychiatric disorders * drug use (alcohol, psychoactive medication) * strong headache * pregnancy
| Milestone | iTBS Group | cTBS Group |
|---|---|---|
| Started | 21 | 20 |
| Completed | 20 | 20 |
| Not completed | 1 | 0 |
Time frame: 3 hours
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| cTBS | 0/20 (0.0%) | 0/20 (0.0%) | 0/20 (0.0%) |
| iTBS | 0/20 (0.0%) | 0/20 (0.0%) | 0/20 (0.0%) |
| Sham iTBS | 0/21 (0.0%) | 0/21 (0.0%) | 1/21 (4.8%) |
| Sham cTBS | 0/20 (0.0%) | 0/20 (0.0%) | 0/20 (0.0%) |
| Term | Organ system | cTBS | iTBS | Sham iTBS | Sham cTBS |
|---|---|---|---|---|---|
| Nausea | Cardiac disorders | 0/20 | 0/20 | 1/21 | 0/20 |
| Facility | City | Country | Status |
|---|---|---|---|
| Laboratory for Cognitive and Neurological Sciences | Fribourg | Switzerland |