NCT03148470

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 10, 2020

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

1.8 years

First QC Date

May 1, 2017

Results QC Date

October 7, 2019

Last Update Submit

April 11, 2020

Conditions

Languages

Keywords

theta burst stimulationLanguage switchingdorsolateral prefrontal cortex

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Nonverbal Switching

    Within 30 minutes after intervention

Study Arms (2)

intermittent theta burst stimulation

EXPERIMENTAL

intermittent theta burst stimulation (iTBS) + Sham iTBS

Device: Sham iTBSDevice: intermittent theta burst stimulation (iTBS)

continuous theta burst stimulation

EXPERIMENTAL

continuous theta burst stimulation (cTBS) + Sham cTBS

Device: Sham cTBSDevice: continuous theta burst stimulation (cTBS)

Interventions

Sham iTBSDEVICE

Placebo stimulation for the iTBS group

intermittent theta burst stimulation
Sham cTBSDEVICE

Placebo stimulation for the cTBS group

continuous theta burst stimulation
intermittent theta burst stimulation (iTBS)DEVICE

Excitatory theta burst stimulation

intermittent theta burst stimulation
continuous theta burst stimulation (cTBS)DEVICE

inhibitory theta burst stimulation

continuous theta burst stimulation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for Cognitive and Neurological Sciences

Fribourg, 1700, Switzerland

Location

Related 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. doi: 10.1016/j.bandl.2005.01.003.

    PMID: 16098377BACKGROUND

  • 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: 25034472BACKGROUND

  • 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: 21036201BACKGROUND

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

CommunicationBehavior

Results Point of Contact

Title
Prof. Dr. Jean-Marie Annoni
Organization
University of Fribourg
jean-marie.annoni@unifr.ch
++4126 306 3802

Study Officials

  • Jean-Marie Annoni, Prof. Dr.

    University of Fribourg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 11, 2017

Study Start

September 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2019

Last Updated

April 22, 2020

Results First Posted

April 10, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)