NCT02840396

Brief Summary

The purpose of this study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (DLPFC) on language production.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

July 19, 2016

Last Update Submit

October 7, 2019

Conditions

Language

Keywords

languageDLPFCrTMSExecutive Functions

Outcome Measures

Primary Outcomes (1)

  • Language production

    Picture naming task and word translation task

    within 30 mins after rTMS/sham rTMS

Secondary Outcomes (1)

  • non-verbal executive functions task

    within 30 mins after rTMS/sham rTMS

Study Arms (2)

rTMS

EXPERIMENTAL
Device: rTMS

Sham rTMS

SHAM COMPARATOR
Device: Sham rTMS

Interventions

rTMSDEVICE

repetitive TMS (rTMS) can lead to temporary increases or decreases (depending on the protocol used) in excitability of the targeted area. This change in excitability has been shown to last beyond the duration of the stimulation.

rTMS
Sham rTMSDEVICE

Sham rTMS (or placebo rTMS) refers to a control condition in which no physiological effect on the targeted cortical region occurs.

Sham rTMS

Eligibility Criteria

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

You may qualify if:

  • L1 French, 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 body
  • history of neurological diseases or psychiatric disorders
  • drug use (alcohol, psychoactive medication)
  • developmental language disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory for Cognitive and Neurological Sciences

Fribourg, 1700, Switzerland

Location

Related Publications (6)

  • Osaka N, Otsuka Y, Hirose N, Ikeda T, Mima T, Fukuyama H, Osaka M. Transcranial magnetic stimulation (TMS) applied to left dorsolateral prefrontal cortex disrupts verbal working memory performance in humans. Neurosci Lett. 2007 May 18;418(3):232-5. doi: 10.1016/j.neulet.2007.01.087. Epub 2007 Apr 8.

    PMID: 17467169BACKGROUND

  • Cotelli M, Calabria M, Manenti R, Rosini S, Zanetti O, Cappa SF, Miniussi C. Improved language performance in Alzheimer disease following brain stimulation. J Neurol Neurosurg Psychiatry. 2011 Jul;82(7):794-7. doi: 10.1136/jnnp.2009.197848. Epub 2010 Jun 23.

    PMID: 20574108BACKGROUND

  • 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

  • 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

  • Fabbro F, Skrap M, Aglioti S. Pathological switching between languages after frontal lesions in a bilingual patient. J Neurol Neurosurg Psychiatry. 2000 May;68(5):650-2. doi: 10.1136/jnnp.68.5.650.

    PMID: 10766900BACKGROUND

  • Abutalebi J, Green D. Bilingual language production: The neurocognition of language representation and control. Journal of Neurolinguistics, 20, 242-275, 2007.

    BACKGROUND

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Jean-Marie Annoni, Prof. Dr.

    University of Fribourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

July 19, 2016

First Posted

July 21, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

October 9, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)