ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03094520
Previous Study | Return to List | Next Study

Cognitive Embodiment Activation by tDCS (GEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03094520
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Healthy Young Adults Device: tDCS Device: sham-tDCS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation (tDCS) on Gestural-verbal Brain Associations: the Role of Cognitive Embodiment
Actual Study Start Date : May 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : October 2018

Arm Intervention/treatment
Experimental: Anodal tDCS + semantic, motor, attentional tasks
Combination of gestural (subjects have to indicate if the gesture is related to the word), attentional and motor tasks with anodal stimulation
Device: tDCS
Transcranial direct current stimulation (tDCS)
Other Name: Neuroconn

Sham Comparator: Sham tDCS + semantic, motor, attentional tasks
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
sham stimulation
Other Name: Neuroconn




Primary Outcome Measures :
  1. response time in semantic decision task [ Time Frame: assessed during stimulation or sham stimulation of semantic decision task (last approximately 10 min) at specific timepoint within 2 weeks ]
    Comparing response time in semantic decision task under anodal tDCS compared to sham stimulation (change from sham stimulation)

  2. performance in attentional load task [ Time Frame: assessed during stimulation or sham stimulation of attentional load task (last approximately 6 min) at specific timepoint within 2 weeks ]

    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)


  3. performance in motor task [ Time Frame: assessed during stimulation or sham stimulation of motor task (last approximately 4 min) at specific timepoint within 2 weeks ]

    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)



Secondary Outcome Measures :
  1. Functional connectivity predictors [ Time Frame: assessed during baseline testing ]
    Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness

  2. Other cognitive outcomes: change in working memory performance [ Time Frame: change in working memory performance from baseline after 30 min (approximately) ]
    Digit span backward performance assessed before (baseline) and after stimulation to test for tDCS effects on working memory

  3. Other cognitive outcomes: change in Attention performance [ Time Frame: change in attention performance from baseline after 30 min (approximately) ]
    Digit span forward performance assessed before baseline) and after stimulation to test for tDCS effects on attention



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right handedness
  • unobtrusive neuropsychological screening

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094520


Contacts
Contact: Anes Floeel, Prof. agnes.floeel@charite.de
Contact: Daria Antonenko, Dr. daria.antonenko@charite.de

Locations
Germany
Charité Recruiting
Berlin, Germany, 10117
Contact: Daria Antonenko, Dr       daria.antonenko@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Agnes Floeel, Prof