Healthy Older AdultsTRAINSTIM2NCT02795702
tDCS Effects on Associative Learning in Older Adults of Working Age
A study testing tDCS and training in people with Healthy Older Adults, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Older Adults
- What is being tested?
- tDCS and training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2017to 1 May 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: older in working age (50-65 years)
- Right handedness
- unobtrusive neuropsychological screening
Who cannot join
- Mild cognitive impairment (MCI) or other neurological diseases.
- 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 MRI (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 Associative Learning in Older Adults
The aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals.
- Conditions
- Healthy Older Adults
- Being tested
- tDCS, training
- Keywords
- tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Transcranial direct current stimulation
trainingBehavioural
Also called intensive training of picture-word associations
Cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS + training | Experimental | Combination of intensive training of picture-word associations (Wernicko task) with anodal stimulation Receives: Device: tDCS; Behavioral: training |
| Sham tDCS + training | Sham comparator | Combination of intensive training of picture-word associations (Wernicko task) with sham stimulation Receives: Device: tDCS; Behavioral: training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in a verbal associative learning paradigm under anodal tDCS compared to sham
Investigation whether anodal tDCS leads to improved performance accuracy in the Wernicko task compared to sham stimulation.
Measured: assessed immediately after training period (several learning blocks) compared to sham
Secondary outcomes (5)
Functional connectivity predictors
Connectivity as measured by resting-state fMRI during baseline as predictors for performance and tDCS responsiveness
Measured: assessed during baseline testing
Structural predictors
Microstructure of white matter (Fractional Anisotropy) as measured by diffusion tensor imaging during baseline as predictors for performance and tDCS responsiveness
Measured: assessed during baseline testing
Genotyping of learning related polymorphisms
To assess predictors of positive reaction to brain stimulation, genotyping of several learning related polymorphisms will be performed
Measured: : assessed during baseline screening
Other cognitive outcome: Attention
Digit span forward performance assessed before and after stimulation to test for tDCS effects on attention
Measured: assessed directly before and immediately after tDCS + training compared to
Other cognitive outcome: Working memory
Digit span backwards performance assessed before and after stimulation to test for tDCS effects on working memory
Measured: assessed directly before and immediately after tDCS + training compared to
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study start1 Apr 2017
- Primary completion1 Mar 2018
- Study completion1 May 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 Older 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
- 14 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 Flöel, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795702
- Sponsor's protocol ID
- TRAINSTIM2.B
- Acronym
- TRAINSTIM2
- Status last verified
- May 2021
- First submitted
- 5 Apr 2016
- Last updated
- 7 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 18303984Breitenstein C, Knecht S. Development and validation of a language learning model for behavioral and functional-imaging studies. J Neurosci Methods. 2002 Mar 15;114(2):173-9. doi: 10.1016/s0165-0270(01)00525-8.
PubMed 11856568Breitenstein C, Jansen A, Deppe M, Foerster AF, Sommer J, Wolbers T, Knecht S. Hippocampus activity differentiates good from poor learners of a novel lexicon. Neuroimage. 2005 Apr 15;25(3):958-68. doi: 10.1016/j.neuroimage.2004.12.019.
PubMed 15808996
Study at a glance
From the registry record, last updated by the sponsor on 7 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 Associative Learning in Older Adults
- ClinicalTrials.gov ID
- NCT02795702
- Acronym / sponsor ID
- TRAINSTIM2 / TRAINSTIM2.B
- Conditions
- Healthy Older Adults
- Keywords
- tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 10 Jun 2016 (estimated)
- 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 aim of this study is to investigate whether a tDCS-accompanied training of audio-visual associative memory leads to a performance improvement in healthy older individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS + training | Experimental | Device: tDCS, Behavioral: trainingCombination of intensive training of picture-word associations (Wernicko task) with anodal stimulation |
| Sham tDCS + training | Sham comparator | Device: tDCS, Behavioral: trainingCombination of intensive training of picture-word associations (Wernicko task) with sham stimulation |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: older in working age (50-65 years)
- Right handedness
- unobtrusive neuropsychological screening
Key exclusion criteria (4 listed)
- Mild cognitive impairment (MCI) or other neurological diseases.
- 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 MRI (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 |
|---|---|---|
| tDCSTranscranial direct current stimulation | Device | Anodal tDCS + training, Sham tDCS + training |
| trainingAlso: intensive training of picture-word associationsCognitive training | Behavioural | Anodal tDCS + training, Sham tDCS + training |
Primary outcome
Performance in a verbal associative learning paradigm under anodal tDCS compared to sham
Time frame: assessed immediately after training period (several learning blocks) compared to sham
Investigation whether anodal tDCS leads to improved performance accuracy in the Wernicko task compared to sham stimulation.
5 secondary outcomes
Functional connectivity predictors
Time frame: assessed during baseline testing
Structural predictors
Time frame: assessed during baseline testing
Genotyping of learning related polymorphisms
Time frame: : assessed during baseline screening
Other cognitive outcome: Attention
Time frame: assessed directly before and immediately after tDCS + training compared to
Other cognitive outcome: Working memory
Time frame: assessed directly before and immediately after tDCS + training compared to
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 7 May 2021.
- 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.
- Background: PubMed 11856568Breitenstein C, Knecht S. Development and validation of a language learning model for behavioral and functional-imaging studies. J Neurosci Methods. 2002 Mar 15;114(2):173-9. doi: 10.1016/s0165-0270(01)00525-8.
- Background: PubMed 15808996Breitenstein C, Jansen A, Deppe M, Foerster AF, Sommer J, Wolbers T, Knecht S. Hippocampus activity differentiates good from poor learners of a novel lexicon. Neuroimage. 2005 Apr 15;25(3):958-68. doi: 10.1016/j.neuroimage.2004.12.019.
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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 Flöel, Prof. Dr. principal investigator
Charite University, Berlin, Germany
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 and training in people with Healthy Older 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 3 inclusion and 4 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 7 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?
Performance in a verbal associative learning paradigm under anodal tDCS compared to sham (time frame: assessed immediately after training period (several learning blocks) compared to sham). 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 NCT02795702, 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 7 May 2021.