NCT02289521

Brief Summary

This study aims to evaluate the effect of stimulation of prefrontal regions on language performance (e.g. word translation and picture naming). During the language tests, cortical activity will be registered using electroencephalography (EEG) which will provide supplementary information about the cerebral processus involved in language production and management of two languages in bilingual subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

October 8, 2014

Last Update Submit

April 30, 2018

Conditions

LanguageExecutive Dysfunction

Keywords

Transcranial Direct Current stimulationExecutive functionBilingualismDorsolateral Prefrontal Cortex

Outcome Measures

Primary Outcomes (2)

  • Changes in language performance using behavioural measures

    Modifications in language performance using behavioural measures (response reaction time and response accuracy) caused by tDCS.

    Starting October 2014 up to 36 months

  • Changes in language performance using EEG data

    Modifications in language performance using EEG data (e.g. modification in waveforms and topographic maps at 250-300 ms time-window after the presentation of stimuli) caused by tDCS.

    Starting October 2014 up to 36 months

Study Arms (2)

Anodal Transcranial Direct Current Stim.

ACTIVE COMPARATOR

Transcranial Direct Current Stimulation Anodal (A-tDCS): Active anodal electrode over F3 (EEG system) and return electrode over right supraorbital area. A 1.5mA current will flow between the electrodes for 20 min. To decrease current-induced injuries, at the beginning the current reaches from 0 to 1.5mA during 30 seconds (fade-in), and decreases from 1.5mA to 0 in 15 seconds at the end (fade-out).

Device: Transcranial Direct Current Stimulation

Sham Transcranial Direct Current Stim.

SHAM COMPARATOR

Transcranial Direct Current Stimulation Sham: The parameters mimics the A-tDCS (electrode placement, fade-in and current intensity), except the stimulation duration: the current will reach 1.5mA in 30 sec (fade-in) and lasts only for 30 sec (to give the initial sensation of stimulation). After the stimulation, language performance and EEG will be recorded. Order of interventions (anodal - sham) will be randomised across subjects.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current StimulationDEVICE

We will use a non-invasive, reversible transcranial direct current stimulation (tDCS) using a low-intensity electrical current. We will use Anodal and Sham tDCS. * Anodal: Active anodal electrode over F3 (EEG system) and return electrode over right supraorbital area. A 1.5mA current will flow between the electrodes for 20min. To decrease current-induced injuries, at the beginning, the current reaches from 0 to 1.5mA during 30 seconds (fade-in), and decreases from 1.5mA to 0 in 15 seconds at the end (fade-out). * Sham: The parameters mimics the A-tDCS (i.e. electrode placement, fade-in and current intensity), except the duration of stimulation: the current will reach to 1.5mA in 30 seconds (fade-in) and lasts only for 30 seconds (to give the initial sensation of stimulation).

Also known as: tDCS
Anodal Transcranial Direct Current Stim.Sham Transcranial Direct Current Stim.

Eligibility Criteria

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

You may qualify if:

  • Healthy subjects
  • years old
  • Right-handed
  • French as their mother tongue and intermediate level in English.

You may not qualify if:

  • Presence of unstable medical condition (e.g. active epilepsy with seizure in the last 2 years)
  • Developmental problem of language
  • Metallic head implants
  • Scalp skin lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Fribourg

Fribourg, 1700, Switzerland

Location

MeSH Terms

Conditions

Language

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

CommunicationBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Jean-Marie Annoni, MD

    University of Fribourg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 8, 2014

First Posted

November 13, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2015

Study Completion

May 1, 2018

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

CH(1)