Healthy Young AdultsGESTNCT03094520
Cognitive Embodiment Activation by tDCS
A study testing tDCS in people with Healthy Young Adults, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2016to 1 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right handedness
- unobtrusive neuropsychological screening
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Direct Current Stimulation (tDCS) on Gestural-verbal Brain Associations: the Role of Cognitive Embodiment
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.
- Conditions
- Healthy Young Adults
- Being tested
- tDCS, sham-tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called Neuroconn
Transcranial direct current stimulation (tDCS)
sham-tDCSDevice
Also called Neuroconn
sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: sham-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
response time in semantic decision task
Comparing response time in semantic decision task under anodal tDCS compared to sham stimulation (change from sham stimulation)
Measured: 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)
Measured: 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)
Measured: 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
Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness
Measured: assessed during baseline testing
Other cognitive outcomes: change in working memory performance
Digit span backward performance assessed before (baseline) and after stimulation to test for tDCS effects on working memory
Measured: change in working memory performance from baseline after 30 min (approximately)
Other cognitive outcomes: change in Attention performance
Digit span forward performance assessed before baseline) and after stimulation to test for tDCS effects on attention
Measured: change in attention performance from baseline after 30 min (approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 May 2016
- Primary completion1 May 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy Young AdultsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Flöel, Charite University, Berlin, Germany
- Investigators
- Agnes Floeel, Prof, Principal investigator, Charite Universitätsmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094520
- Sponsor's protocol ID
- GEST
- Acronym
- GEST
- Status last verified
- May 2021
- First submitted
- 24 Feb 2017
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25558040Floel 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.
PubMed 12911767Floel 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.
PubMed 18303984
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation (tDCS) on Gestural-verbal Brain Associations: the Role of Cognitive Embodiment
- ClinicalTrials.gov ID
- NCT03094520
- Acronym / sponsor ID
- GEST / GEST
- Conditions
- Healthy Young Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS + semantic, motor, attentional tasks | Experimental | Device: tDCSCombination of gestural (subjects have to indicate if the gesture is related to the word), attentional and motor tasks with anodal stimulation |
| Sham tDCS + semantic, motor, attentional tasks | Sham comparator | Device: sham-tDCSCombination of gestural (subjects have to indicate if the gesture is related to the word), attentional and motor tasks with sham stimulation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Right handedness
- unobtrusive neuropsychological screening
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: NeuroconnTranscranial direct current stimulation (tDCS) | Device | Anodal tDCS + semantic, motor, attentional tasks |
| sham-tDCSAlso: Neuroconnsham stimulation | Device | Sham tDCS + semantic, motor, attentional tasks |
Primary outcome
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)
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)
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)
3 secondary outcomes
Functional connectivity predictors
Time frame: assessed during baseline testing
Other cognitive outcomes: change in working memory performance
Time frame: change in working memory performance from baseline after 30 min (approximately)
Other cognitive outcomes: change in Attention performance
Time frame: change in attention performance from baseline after 30 min (approximately)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Background: PubMed 25558040Cohen-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.
- Background: PubMed 12911767Floel 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.
- Background: PubMed 18303984Floel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes Floeel, Prof principal investigator
Charite Universitätsmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Healthy Young Adults, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094520, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.