LanguagesNCT03148470

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

A study testing intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS) in people with Languages, run by Jean-Marie Annoni at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Languages
What is being tested?: intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 1 siteSwitzerland
Study dates: Sep 2016to Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

L1 (Swiss)German, knowledge of English as a foreign language
18-45 years of age
right-handedness

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Laboratory for Cognitive and Neurological Sciences
Fribourg, 1700

Other trials in Switzerland

About this study

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

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.

Read the 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.

Conditions: Languages
Being tested: Sham iTBS, Sham cTBS, intermittent theta burst stimulation (iTBS), continuous theta burst stimulation (cTBS)
Keywords: theta burst stimulation, Language switching, dorsolateral prefrontal cortex
Medical subject headings: Language

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sham iTBSDevice
Placebo stimulation for the iTBS group
Sham cTBSDevice
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

Study groups in NCT03148470
Study group	Role	What they receive
intermittent theta burst stimulation	Experimental	intermittent theta burst stimulation (iTBS) + Sham iTBS Receives: Device: Sham iTBS; Device: intermittent theta burst stimulation (iTBS)
continuous theta burst stimulation	Experimental	continuous theta burst stimulation (cTBS) + Sham cTBS Receives: Device: Sham cTBS; Device: continuous theta burst stimulation (cTBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Within 30 minutes after intervention

Secondary outcomes (1)

Nonverbal Switching
Nonverbal Switching: response times
Measured: Within 30 minutes after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2016Jul 2019

First posted11 May 2017
Study startSep 2016
Primary completionJul 2018
Study completionJul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for LanguagesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03148470
Sponsor's protocol ID: SNF325130_156937_4
Status last verified: Apr 2020
First submitted: 1 May 2017
Last updated: 22 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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.
PubMed 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.
PubMed 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.
PubMed 21036201

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Languages trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Theta Burst Stimulation Over the Left Dorsolateral Prefrontal Cortex on Language Switching and Cognitive Flexibility
ClinicalTrials.gov ID: NCT03148470
Acronym / sponsor ID: SNF325130_156937_4
Conditions: Languages
Keywords: theta burst stimulation, Language switching, dorsolateral prefrontal cortex
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Jean-Marie AnnoniUniversity, hospital or other
Study start: Sep 2016 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Jul 2019 (actual)
First posted: 11 May 2017 (actual)
Results: Posted 10 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Procedure:

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

L1 (Swiss)German, knowledge of English as a foreign language
18-45 years of age
right-handedness

Key exclusion criteria (7 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sham iTBSPlacebo stimulation for the iTBS group	Device	intermittent theta burst stimulation
Sham cTBSPlacebo stimulation for the cTBS group	Device	continuous theta burst stimulation
intermittent theta burst stimulation (iTBS)Excitatory theta burst stimulation	Device	intermittent theta burst stimulation
continuous theta burst stimulation (cTBS)inhibitory theta burst stimulation	Device	continuous theta burst stimulation

Primary outcome

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.

1 secondary outcome

Nonverbal Switching
Time frame: Within 30 minutes after intervention

Results and safety

Results posted to the registry on 10 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
iTBS Group	21	20
cTBS Group	20	20

Primary outcome: RTs for Picture Naming With the Factors Language (L1, L2) and Block (Switching, Non-Switching)

Time frame: Within 30 minutes after intervention. Mean (Standard Deviation). Unit: Milliseconds

Measure	RTs for PN After Intermittent Theta Burst Stimulation n = 20	RTs for PN After Continuous Theta Burst Stimulation n = 20	RTs for Picture Naming in L1 n = 40	RTs for Picture Naming in L2 n = 40	RTs for Picture Naming in the Non-switching Blocks n = 40	RTs for Picture Naming in the Switching Blocks n = 40
Value	1103.32 (126)	1107.26 (131)	1098.82 (405)	1158.91 (432)	1081.14 (414)	1175.24 (420)

RTs for PN After Intermittent Theta Burst Stimulation vs RTs for PN After Continuous Theta Burst Stimulation vs RTs for Picture Naming in L1 vs RTs for Picture Naming in L2 vs RTs for Picture Naming in the Non-switching Blocks vs RTs for Picture Naming in the Switching Blocks: p = 0.932, Mixed Models Analysis

Population analysed: As a primary outcome we compared RTs following iTBS vs cTBS. Sham-TBS is only used to have a baseline control between the two groups

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
cTBS	0 of 20 (0%)	0 of 20 (0%)	0 of 20
iTBS	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Sham iTBS	0 of 21 (0%)	1 of 21 (4.8%)	0 of 21
Sham cTBS	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16098377Holtzheimer 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.
Background: PubMed 25034472Lefaucheur 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.
Background: PubMed 21036201Nardone 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jean-Marie Annoni, Prof. Dr. principal investigator

University of Fribourg

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing intermittent theta burst stimulation (iTBS) and continuous theta burst stimulation (cTBS) in people with Languages, run by Jean-Marie Annoni at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RTs for Picture Naming With the Factors Language (L1, L2) and Block (Switching, Non-Switching) (time frame: Within 30 minutes after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03148470, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.