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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03148470
Other study ID # SNF325130_156937_4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date July 2019

Study information

Verified date April 2020
Source University of Fribourg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date July 2019
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Sham iTBS
Placebo stimulation for the iTBS group
Sham cTBS
Placebo stimulation for the cTBS group
intermittent theta burst stimulation (iTBS)
Excitatory theta burst stimulation
continuous theta burst stimulation (cTBS)
inhibitory theta burst stimulation

Locations

Country Name City State
Switzerland Laboratory for Cognitive and Neurological Sciences Fribourg

Sponsors (1)

Lead Sponsor Collaborator
Jean-Marie Annoni

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. — View Citation

Lefaucheur JP, André-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, Jääskeläinen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schönfeldt-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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
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.
Within 30 minutes after intervention
Secondary Nonverbal Switching Nonverbal Switching: response times Within 30 minutes after intervention
See also
  Status Clinical Trial Phase
Recruiting NCT02577757 - Establishing the Language Network With Independent Component Analysis of Resting State MRI N/A