Effect of rTMS of the Dorsolateral Prefrontal Cortex on L... | NCT02840396

Studies
Effect of rTMS of the Dorsolateral Prefrontal Cortex on Language Production in Healthy Participants

NCT02840396

Sponsor

Jean-Marie Annoni

Status

Completed

Last Update Posted

Oct 9, 2019Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Language

Interventions

rTMS
Sham rTMS

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jun 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Jul 19, 2016

First Submission Date that Met QC Criteria

Jul 20, 2016

First Posted Date

Jul 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2019

Last Update Posted Date

Oct 9, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jean-Marie Annoni, Prof. Dr. med., University of FribourgSponsor-Investigator

Lead Sponsor

Jean-Marie AnnoniOTHER

Collaborators

Name	Class
Insel Gruppe AG, University Hospital Bern	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Background:

Several studies investigating healthy or clinical populations have shown that (r)TMS applied over the dorsolateral prefrontal cortex (DLPFC) has an effect on language-related processes such as verbal working memory (Osaka et al., 2007), sentence comprehension (Cotelli et al., 2011) and language switching (Holtzheimer et al., 2005, Nardone et al., 2011).

Clinical observations and neuroimaging studies seem to confirm the role of executive functions and frontal structures in language processing in monolingual and bilingual subjects (e.g. Fabbro et al., 2000, Abutalebi & Green 2007). However, only few studies investigated the effects of modulation of cognitive control-networks on lexical access.

Aim and procedure:

The study will investigate the role of the DLPFC and executive functioning in L1 and L2 language processing. The core question is whether rTMS over the DLPFC will influence lexical access and language production.

Each participant will take part in two sessions: 1. rTMS session 2. Sham rTMS session. After the application of rTMS/Sham rTMS, the participants will conduct two language tasks (translation, picture naming) and a non-verbal task, while the EEG is recorded.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rTMS	Experimental		Device: rTMS
Sham rTMS	Sham Comparator		Device: Sham rTMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rTMS	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Language production	Picture naming task and word translation task	within 30 mins after rTMS/sham rTMS

Secondary Outcomes

Measure	Description	Time Frame
non-verbal executive functions task		within 30 mins after rTMS/sham rTMS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Marie Annoni, Prof. Dr.	University of Fribourg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratory for Cognitive and Neurological Sciences		Fribourg		1700	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17467169	Background	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.
20574108	Background

ID	Term
D003142	Communication
D001519	Behavior