AgingTrainStimNCT03838211
Brain Stimulation and Cognitive Training in Healthy Older Adults
A study testing Anodal tDCS and Intensive cognitive training in people with Aging, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in healthy older individuals. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Anodal tDCS and Intensive cognitive 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
- 56 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2018to 25 Mar 2020
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older adults (65 - 80 years);
- Right handedness;
- Unobtrusive neuropsychological screening
Who cannot join
- Mild cognitive impairment (MCI) or dementia; other neurodegenerative neurological disorders; epilepsy; previous stroke;
- Severe and untreated medical conditions that precludes participation in the training, as determined by responsible physician;
- History of severe alcoholism or use of drugs;
- Severe psychiatric disorders such as depression (if not in remission) or psychosis;
- 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: tDCS-accompanied Cognitive Training Effects in Healthy Older Adults - Randomised, Sham Controlled, Interventional Study
The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in healthy older individuals.
Read the detailed description
The goal of the present study is to assess behavioral (primary) and neural effects of a multi-session cognitive training combined with transcranial direct current stimulation (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various cognitive functions by modulating cortical excitability in young adults, but its behavioral impact and underlying mechanisms in aging still need to be elucidated. Healthy older adults will participate in a three-week cognitive training with concurrent online tDCS application. Cognitive performance (primary), as well as structural and functional imaging data will be examined before, during and after the intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. Furthermore, to assess neural correlates of performance improvement, functional and structural parameters will be measured with MRI before and after training. Follow-up sessions to assess long-term effects are planned four weeks and six months after the post assessment. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training, as compared to training alone, in older adults. Moreover, improved understanding of tDCS effects on cognitive training performance and underlying neural correlates may help to develop novel approaches for cognitive decline in healthy and pathological aging.
- Conditions
- Aging
- Being tested
- Anodal tDCS, Intensive cognitive training
- Keywords
- memory, brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)
Intensive cognitive trainingBehavioural
Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions
| Study group | Role | What they receive |
|---|---|---|
| stimulation group | Experimental | Anodal tDCS + intensive cognitive Training Receives: Device: Anodal tDCS; Behavioral: Intensive cognitive training |
| sham group | Sham comparator | Sham tDCS + intensive cognitive Training Receives: Behavioral: Intensive cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory training performance (Letter Updating task)
Performance in a memory training task (Letter updating) under anodal tDCS compared to sham condition;operationalized by working Memory Updating performance assessed with number of correctly recalled letter lists in the letter updating task, analyzed immediately after training period (anodal condition versus sham)
Measured: 3 weeks
Secondary outcomes (4)
Working memory training performance (Markov task)
Performance in second memory training task (Markov decision making) under anodal tDCS compared to sham condition, analyzed immediately after training period (anodal condition versus sham)
Measured: 3 weeks
Transfer outcomes
Performance in cognitive transfer tasks, comparing performance immediately before and after training period (anodal condition versus sham)
Measured: 3 weeks
Long-term outcomes
Long-term performance in training and transfer tasks, comparing performance immediately before and after training period with performance at 4 weeks and 6-months after training period (anodal condition versus sham)
Measured: 4 weeks after training, 6 months after 4-week follow-up
Neural correlates
Structural and functional neural correlates of the intervention, as measured by structural, functional resting-state and diffusion weighted MRI, immediately before and after the intervention and 6 months after follow-up (anodal condition versus sham)
Measured: 3 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Oct 2018
- Primary completion1 Dec 2019
- Study completion25 Mar 2020
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 AgingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden
- Responsible party
- Sponsor
- Investigators
- Agnes Flöel, Prof., Study director, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838211
- Sponsor's protocol ID
- TrainStim3
- Acronym
- TrainStim
- Status last verified
- Apr 2021
- First submitted
- 1 Feb 2019
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thams F, Li SC, Floel A, Antonenko D. Functional Connectivity and Microstructural Network Correlates of Interindividual Variability in Distinct Executive Functions of Healthy Older Adults. Neuroscience. 2023 Aug 21;526:61-73. doi: 10.1016/j.neuroscience.2023.06.005. Epub 2023 Jun 14.
PubMed 37321368Antonenko D, Fromm AE, Thams F, Grittner U, Meinzer M, Floel A. Microstructural and functional plasticity following repeated brain stimulation during cognitive training in older adults. Nat Commun. 2023 Jun 2;14(1):3184. doi: 10.1038/s41467-023-38910-x.
PubMed 37268628Antonenko D, Thams F, Uhrich J, Dix A, Thurm F, Li SC, Grittner U, Floel A. Effects of a Multi-Session Cognitive Training Combined With Brain Stimulation (TrainStim-Cog) on Age-Associated Cognitive Decline - Study Protocol for a Randomized Controlled Phase IIb (Monocenter) Trial. Front Aging Neurosci. 2019 Aug 16;11:200. doi: 10.3389/fnagi.2019.00200. eCollection 2019.
PubMed 31474848
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS-accompanied Cognitive Training Effects in Healthy Older Adults - Randomised, Sham Controlled, Interventional Study
- ClinicalTrials.gov ID
- NCT03838211
- Acronym / sponsor ID
- TrainStim / TrainStim3
- Conditions
- Aging
- Keywords
- memory, brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Technische Universität Dresden
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 12 Feb 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.
The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training of working memory leads to performance improvement in healthy older individuals.
Detailed description
The goal of the present study is to assess behavioral (primary) and neural effects of a multi-session cognitive training combined with transcranial direct current stimulation (tDCS). Many studies to date have found tDCS to be an efficient method to enhance various cognitive functions by modulating cortical excitability in young adults, but its behavioral impact and underlying mechanisms in aging still need to be elucidated. Healthy older adults will participate in a three-week cognitive training with concurrent online tDCS application. Cognitive performance (primary), as well as structural and functional imaging data will be examined before, during and after the intervention. In order to draw conclusions about the effect of tDCS in addition to cognitive training, a control group, receiving sham stimulation during training, will be assessed. Furthermore, to assess neural correlates of performance improvement, functional and structural parameters will be measured with MRI before and after training. Follow-up sessions to assess long-term effects are planned four weeks and six months after the post assessment. The results of the study will offer valuable insights into efficacy of combined tDCS and cognitive training, as compared to training alone, in older adults. Moreover, improved understanding of tDCS effects on cognitive training performance and underlying neural correlates may help to develop novel approaches for cognitive decline in healthy and pathological aging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stimulation group | Experimental | Device: Anodal tDCS, Behavioral: Intensive cognitive trainingAnodal tDCS + intensive cognitive Training |
| sham group | Sham comparator | Behavioral: Intensive cognitive trainingSham tDCS + intensive cognitive Training |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Older adults (65 - 80 years);
- Right handedness;
- Unobtrusive neuropsychological screening
Key exclusion criteria (5 listed)
- Mild cognitive impairment (MCI) or dementia; other neurodegenerative neurological disorders; epilepsy; previous stroke;
- Severe and untreated medical conditions that precludes participation in the training, as determined by responsible physician;
- History of severe alcoholism or use of drugs;
- Severe psychiatric disorders such as depression (if not in remission) or psychosis;
- 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 |
|---|---|---|
| Anodal tDCSAnodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA) | Device | stimulation group |
| Intensive cognitive trainingIntensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions | Behavioural | sham group, stimulation group |
Primary outcome
Working memory training performance (Letter Updating task)
Time frame: 3 weeks
Performance in a memory training task (Letter updating) under anodal tDCS compared to sham condition;operationalized by working Memory Updating performance assessed with number of correctly recalled letter lists in the letter updating task, analyzed immediately after training period (anodal condition versus sham)
4 secondary outcomes
Working memory training performance (Markov task)
Time frame: 3 weeks
Transfer outcomes
Time frame: 3 weeks
Long-term outcomes
Time frame: 4 weeks after training, 6 months after 4-week follow-up
Neural correlates
Time frame: 3 weeks, 6 months
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 3 May 2021.
- Derived from this study: PubMed 37321368Thams F, Li SC, Floel A, Antonenko D. Functional Connectivity and Microstructural Network Correlates of Interindividual Variability in Distinct Executive Functions of Healthy Older Adults. Neuroscience. 2023 Aug 21;526:61-73. doi: 10.1016/j.neuroscience.2023.06.005. Epub 2023 Jun 14.
- Derived from this study: PubMed 37268628Antonenko D, Fromm AE, Thams F, Grittner U, Meinzer M, Floel A. Microstructural and functional plasticity following repeated brain stimulation during cognitive training in older adults. Nat Commun. 2023 Jun 2;14(1):3184. doi: 10.1038/s41467-023-38910-x.
- Derived from this study: PubMed 31474848Antonenko D, Thams F, Uhrich J, Dix A, Thurm F, Li SC, Grittner U, Floel A. Effects of a Multi-Session Cognitive Training Combined With Brain Stimulation (TrainStim-Cog) on Age-Associated Cognitive Decline - Study Protocol for a Randomized Controlled Phase IIb (Monocenter) Trial. Front Aging Neurosci. 2019 Aug 16;11:200. doi: 10.3389/fnagi.2019.00200. eCollection 2019.
- Individual participant dataSharing planned: No
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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. study director
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS and Intensive cognitive training in people with Aging, run by University Medicine Greifswald 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 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: finished, as of the sponsor's last update on 3 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?
Working memory training performance (Letter Updating task) (time frame: 3 weeks). 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 NCT03838211, 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 3 May 2021.