NCT03094520

Brief Summary

The main objective of the proposed research is to extend our understanding of how gesture and language interact, focusing on the role of cognitive embodiment in this interaction, and to explore the neural systems that support links between language and actions systems.

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 May 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

May 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

February 24, 2017

Last Update Submit

May 10, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • response time in semantic decision task

    Comparing response time in semantic decision task under anodal tDCS compared to sham stimulation (change from sham stimulation)

    assessed during stimulation or sham stimulation of semantic decision task (last approximately 10 min) at specific timepoint within 2 weeks

  • performance in attentional load task

    Attentional load task: Participants are presented with a 6 positions ring that includes different shapes, they have to press V when they see a square and N when they see a diamond. They will have to ignore any shapes other than square and diamond within the ring or distractors that appear outside the ring. Comparing performance in attentional load task under anodal tDCS compared to sham stimulation (change from sham stimulation)

    assessed during stimulation or sham stimulation of attentional load task (last approximately 6 min) at specific timepoint within 2 weeks

  • performance in motor task

    Motor Task: Participants are presented with a red Box and they have to click a button each time they see it as fast as they can. Comparing performance in motor task under anodal tDCS compared to sham stimulation (change from sham stimulation)

    assessed during stimulation or sham stimulation of motor task (last approximately 4 min) at specific timepoint within 2 weeks

Secondary Outcomes (3)

  • Functional connectivity predictors

    assessed during baseline testing

  • Other cognitive outcomes: change in working memory performance

    change in working memory performance from baseline after 30 min (approximately)

  • Other cognitive outcomes: change in Attention performance

    change in attention performance from baseline after 30 min (approximately)

Study Arms (2)

Anodal tDCS + semantic, motor, attentional tasks

EXPERIMENTAL

Combination of gestural (subjects have to indicate if the gesture is related to the word), attentional and motor tasks with anodal stimulation

Device: tDCS

Sham tDCS + semantic, motor, attentional tasks

SHAM COMPARATOR

Combination of gestural (subjects have to indicate if the gesture is related to the word), attentional and motor tasks with sham stimulation

Device: sham-tDCS

Interventions

tDCSDEVICE

Transcranial direct current stimulation (tDCS)

Also known as: Neuroconn
Anodal tDCS + semantic, motor, attentional tasks
sham-tDCSDEVICE

sham stimulation

Also known as: Neuroconn
Sham tDCS + semantic, motor, attentional tasks

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Right handedness
  • unobtrusive neuropsychological screening

You may not qualify if:

  • History of severe alcoholism or use of drugs.
  • Severe psychiatric disorders such as depression, psychosis (if not in remission) and severe untreated medical problems.
  • Contraindication for MRT (claustrophobia, metallic implants, ferromagnetic metals in the body, disorders of thermoregulation, pregnant women).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité

Berlin, 10117, Germany

Location

Related Publications (3)

  • Cohen-Maximov T, Avirame K, Floel A, Lavidor M. Modulation of Gestural-verbal Semantic Integration by tDCS. Brain Stimul. 2015 May-Jun;8(3):493-8. doi: 10.1016/j.brs.2014.12.001. Epub 2014 Dec 11.

    PMID: 25558040BACKGROUND
  • Floel A, Ellger T, Breitenstein C, Knecht S. Language perception activates the hand motor cortex: implications for motor theories of speech perception. Eur J Neurosci. 2003 Aug;18(3):704-8. doi: 10.1046/j.1460-9568.2003.02774.x.

    PMID: 12911767BACKGROUND
  • Floel A, Rosser N, Michka O, Knecht S, Breitenstein C. Noninvasive brain stimulation improves language learning. J Cogn Neurosci. 2008 Aug;20(8):1415-22. doi: 10.1162/jocn.2008.20098.

    PMID: 18303984BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Agnes Floeel, Prof

    Charite Universitätsmedizin

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 29, 2017

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

October 1, 2018

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations