HealthyNCT03915483
Transfer Effects of Combined Attentional Filter Exercise and Transcranial Direct Current Stimulation
A study testing transcranial direct current stimulation (tDCS) in people with Healthy, run by German Center for Neurodegenerative Diseases (DZNE) at 1 site in Germany.
Trial summary
Investigation of how a single session of an attentional filter exercise of distractor inhibition combined with tDCS modulates cognitive functions like working memory, decision making and attentional control. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 10 Sep 2018to 31 Dec 2019
- 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-handed
- aged between 18 and 30 years
- normal or corrected to normal vision
- German-speaking
Who cannot join
- dyschromatopsia
- neurological or neuropsychiatric diseases
- low seizure threshold
- neurological medication
- metal implants in the head
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
German Center for Neurodegenerative Diseases
Magdeburg, Saxony-Anhalt, 39120
Marlen Schmicker
About this study
Official title: Cognitive Transfer Effects on Working Memory and Higher Cognitive Functions by Combined Attentional Filter Exercise and tDCS in Healthy Younger Adults
Investigation of how a single session of an attentional filter exercise of distractor inhibition combined with tDCS modulates cognitive functions like working memory, decision making and attentional control.
Read the detailed description
The study is designed as a between subject design with two groups defined by real or sham tDCS. The distractor inhibition exercise is conducted under either sham or real tDCS. Cognitive performance is assessed pre and post tDCS application, complemented by a short-termed follow-up on a consecutive day. Interindividual working memory capacity at baseline is taken into consideration.
- Conditions
- Healthy
- Being tested
- transcranial direct current stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
sham or real tDCS for 10 minutes of 1.5 milliampere (mA) tDCS targeting the prefrontal and the posterior parietal cortex
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Experimental | one session of computerized change detection attentional filter exercise (selective attention) combined with real tDCS Receives: Device: transcranial direct current stimulation (tDCS) |
| sham group | Sham comparator | one session of computerized change detection attentional filter exercise (selective attention) combined with sham tDCS Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance change in computerized attentional filter exercise
attentional filtering performance (in % correct), effects of distractor interference for different set sizes
Measured: 45 minutes on 1st day (pre) and on consecutive day (post)
Reaction change in computerized attentional filter exercise
reaction times (in milliseconds), effects of distractor interference for different set sizes
Measured: 45 minutes on 1st day (pre) and on consecutive day (post)
Performance change in working memory and filtering performance
Working memory and filtering performance (in % correct), effects of distractor interference for different set sizes
Measured: 30 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day
Reaction change in working memory and filtering performance
reaction times (in milliseconds), effects of distractor interference for different set sizes
Measured: 30 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day
Secondary outcomes (7)
Spatial Span
computerized spatial span forward and backward
Measured: 10 minutes per pre-assessment and short-termed follow-up on the consecutive day
Iowa Gambling Task
Decision making performance
Measured: 7 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day
Trait-Anxiety
Assessment of trait anxiety via State-Trait-Anxiety-Inventory on first day
Measured: 2 minutes on first day
State-Anxiety
Daily assessment of state anxiety via State-Trait-Anxiety-Inventory at the beginning of each testing day
Measured: 2 minutes on first and consecutive day
Assessment of Sleep Quality
daily questionnaire assessing subjective rating of sleep of the previous night on 5- to 7-point Likert format and open questions (subjective quality of sleep, current fatigue, duration of sleep); no total score
Measured: 10 minutes on first and consecutive day
Daily Performance Questionnaires
self developed questionnaire assessing subjective performance in tested paradigms (5-point Likert format); no total or sub score; Question 1: How difficult would you rate the task? (lowest (1) = very difficult; highest (5) = very easy) Question 2: Do you think your performance changed in the course of the task? (lowest (1) = strongly worsened; highest (5) = strongly improved)
Measured: 5 minutes on first and consecutive day
Daily Strategy Questionnaires
reporting of used strategies in tested paradigms (open questions; subjects reported in written notes); self developed questionnaire for qualitative analyses of task demands; no scores; Question: Did you use a strategy? If so, please explain shortly.
Measured: 5 minutes on first and consecutive day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start10 Sep 2018
- Primary completion1 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Notger Müller, German Center for Neurodegenerative Diseases (DZNE)
- Investigators
- Notger Müller, Prof. Dr., Principal investigator, German Center for Neurodegenerative Diseases (DZNE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915483
- Sponsor's protocol ID
- MD021.1
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Transfer Effects on Working Memory and Higher Cognitive Functions by Combined Attentional Filter Exercise and tDCS in Healthy Younger Adults
- ClinicalTrials.gov ID
- NCT03915483
- Acronym / sponsor ID
- MD021.1
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)University, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 16 Apr 2019 (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.
Investigation of how a single session of an attentional filter exercise of distractor inhibition combined with tDCS modulates cognitive functions like working memory, decision making and attentional control.
Detailed description
The study is designed as a between subject design with two groups defined by real or sham tDCS. The distractor inhibition exercise is conducted under either sham or real tDCS. Cognitive performance is assessed pre and post tDCS application, complemented by a short-termed follow-up on a consecutive day. Interindividual working memory capacity at baseline is taken into consideration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Experimental | Device: transcranial direct current stimulation (tDCS)one session of computerized change detection attentional filter exercise (selective attention) combined with real tDCS |
| sham group | Sham comparator | Device: transcranial direct current stimulation (tDCS)one session of computerized change detection attentional filter exercise (selective attention) combined with sham tDCS |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- right-handed
- aged between 18 and 30 years
- normal or corrected to normal vision
- German-speaking
Key exclusion criteria (5 listed)
- dyschromatopsia
- neurological or neuropsychiatric diseases
- low seizure threshold
- neurological medication
- metal implants in the head
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 |
|---|---|---|
| transcranial direct current stimulation (tDCS)sham or real tDCS for 10 minutes of 1.5 milliampere (mA) tDCS targeting the prefrontal and the posterior parietal cortex | Device | sham group, tDCS group |
Primary outcome
Performance change in computerized attentional filter exercise
Time frame: 45 minutes on 1st day (pre) and on consecutive day (post)
attentional filtering performance (in % correct), effects of distractor interference for different set sizes
Reaction change in computerized attentional filter exercise
Time frame: 45 minutes on 1st day (pre) and on consecutive day (post)
reaction times (in milliseconds), effects of distractor interference for different set sizes
Performance change in working memory and filtering performance
Time frame: 30 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day
Working memory and filtering performance (in % correct), effects of distractor interference for different set sizes
Reaction change in working memory and filtering performance
Time frame: 30 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day
reaction times (in milliseconds), effects of distractor interference for different set sizes
7 secondary outcomes
Spatial Span
Time frame: 10 minutes per pre-assessment and short-termed follow-up on the consecutive day
Iowa Gambling Task
Time frame: 7 minutes per pre-assessment, post assessment directly after intervention and short-termed follow-up on the consecutive day
Trait-Anxiety
Time frame: 2 minutes on first day
State-Anxiety
Time frame: 2 minutes on first and consecutive day
Assessment of Sleep Quality
Time frame: 10 minutes on first and consecutive day
Daily Performance Questionnaires
Time frame: 5 minutes on first and consecutive day
Daily Strategy Questionnaires
Time frame: 5 minutes on first and consecutive day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Notger Müller, Prof. Dr. principal investigator
German Center for Neurodegenerative Diseases (DZNE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Healthy, run by German Center for Neurodegenerative Diseases (DZNE) 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Apr 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlen Schmicker (+49 3916724505, marlen.schmicker@dzne.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance change in computerized attentional filter exercise (time frame: 45 minutes on 1st day (pre) and on consecutive day (post)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2019.