- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03148470
Impact of Theta Burst Stimulation Over the Left DLPFC on Language Switching
Impact of Theta Burst Stimulation Over the Left Dorsolateral Prefrontal Cortex on Language Switching and Cognitive Flexibility
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Fribourg, Switzerland, 1700
- Laboratory for Cognitive and Neurological Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: intermittent theta burst stimulation
intermittent theta burst stimulation (iTBS) + Sham iTBS
|
Placebo stimulation for the iTBS group
Excitatory theta burst stimulation
|
Experimental: continuous theta burst stimulation
continuous theta burst stimulation (cTBS) + Sham cTBS
|
Placebo stimulation for the cTBS group
inhibitory theta burst stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RTs for Picture Naming With the Factors Language (L1, L2) and Block (Switching, Non-Switching)
Time Frame: 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. |
Within 30 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nonverbal Switching
Time Frame: Within 30 minutes after intervention
|
Nonverbal Switching: response times
|
Within 30 minutes after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean-Marie Annoni, Prof. Dr., University of Fribourg
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SNF325130_156937_4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Languages
-
University Hospital, AngersUnknown
-
Northwestern UniversityWithdrawnPatients | Programming LanguagesUnited States
-
Northwestern UniversityCompletedPatients | Programming LanguagesUnited States
Clinical Trials on Sham iTBS
-
Central South UniversityRecruitingSuicidal Ideation | Suicide and Self-harm | Non Suicidal Self InjuryChina
-
Changping LaboratoryChina Rehabilitation Research CenterRecruiting
-
Central South UniversityRecruitingBipolar Depression | Major Depressive DisorderChina
-
Centre for Addiction and Mental HealthUniversity Health Network, Toronto; University of British ColumbiaRecruiting
-
Medical University of South CarolinaMUSC Center for Biomedical Research Excellence in Stroke RecoveryCompleted
-
Changping LaboratoryHenan Provincial People's HospitalNot yet recruitingAutism Spectrum Disorder
-
Changping LaboratoryChina Rehabilitation Research CenterRecruiting
-
China Medical University HospitalNational Science Council, TaiwanWithdrawnParkinson's Disease | Parkinson's Disease With Freezing of GaitTaiwan
-
Mark HallettNational Institute of Neurological Disorders and Stroke (NINDS)Completed
-
Medical University of South CarolinaVirginia Tech Carilion School of Medicine and Research InstituteTerminatedAddiction | Craving | Nicotine | Smoking, CigaretteUnited States