Impact of Theta Burst Stimulation Over the Left DLPFC on Language Switching

NCT03148470 — Not applicable, Completed, 41 participants, Jean-Marie Annoni

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Impact of Theta Burst Stimulation Over the Left Dorsolateral Prefrontal Cortex on Language Switching and Cognitive Flexibility

RegistryNCT03148470
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, factorial, masking: double, basic science
Enrollment41 (Actual)
SponsorJean-Marie Annoni (Other)
ConditionsLanguages
InterventionsSham iTBS, Sham cTBS, intermittent theta burst stimulation (iTBS), continuous theta burst stimulation (cTBS) (Device)
Datesstart 2016-09-01, primary completion 2018-07-01, completion 2019-07-01, first posted 2017-05-11, last updated 2020-04-22
Locations1 site in Switzerland

Related Papers Related Patents Related Grants Related Experts
All trials for Languages All trials of Sham iTBS All trials of Sham cTBS

-Summary

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.

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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
intermittent theta burst stimulationExperimentalDevice: Sham iTBS; Device: intermittent theta burst stimulation (iTBS)intermittent theta burst stimulation (iTBS) + Sham iTBS
continuous theta burst stimulationExperimentalDevice: Sham cTBS; Device: continuous theta burst stimulation (cTBS)continuous theta burst stimulation (cTBS) + Sham cTBS
  • Sham iTBS (Device): Placebo stimulation for the iTBS group
  • 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

+Outcome measures

Primary outcomes

  • RTs for Picture Naming With the Factors Language (L1, L2) and Block (Switching, Non-Switching) [Within 30 minutes after intervention]: 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.

Secondary outcomes

  • Nonverbal Switching [Within 30 minutes after intervention]: Nonverbal Switching: response times

+Eligibility

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

+Posted results

Participant flow

MilestoneiTBS GroupcTBS Group
Started2120
Completed2020
Not completed10

Outcome results

  • RTs for Picture Naming With the Factors Language (L1, L2) and Block (Switching, Non-Switching) (Primary), Mean, Milliseconds: RTs for PN After Intermittent Theta Burst Stimulation 1103.32 +/- 126; RTs for PN After Continuous Theta Burst Stimulation 1107.26 +/- 131; RTs for Picture Naming in L1 1098.82 +/- 405; RTs for Picture Naming in L2 1158.91 +/- 432; RTs for Picture Naming in the Non-switching Blocks 1081.14 +/- 414; RTs for Picture Naming in the Switching Blocks 1175.24 +/- 420 (p 0.932)
  • Nonverbal Switching (Secondary), Mean, Milliseconds: Intermittent Theta Burst Stimulation 772.07 +/- 159.28; Continuous Theta Burst Stimulation 739.32 +/- 137.23 (p 0.642)

Adverse events

Time frame: 3 hours

ArmDeathsSerious adverse eventsOther adverse events
cTBS0/20 (0.0%)0/20 (0.0%)0/20 (0.0%)
iTBS0/20 (0.0%)0/20 (0.0%)0/20 (0.0%)
Sham iTBS0/21 (0.0%)0/21 (0.0%)1/21 (4.8%)
Sham cTBS0/20 (0.0%)0/20 (0.0%)0/20 (0.0%)

Other adverse events by term

TermOrgan systemcTBSiTBSSham iTBSSham cTBS
NauseaCardiac disorders0/200/201/210/20

+Locations (1)

FacilityCityCountryStatus
Laboratory for Cognitive and Neurological SciencesFribourgSwitzerland

+Publications

  • 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. PMID 16098377
  • 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. PMID 25034472
  • 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. PMID 21036201

+Study documents

+Investigators