AgingTrainStim4NCT04817124
Cognitive Training Combined With Transcranial Direct Current Stimulation in Older Adults in a Home-based Context
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 is feasible as a home-based intervention. Read more about this study
- Who is it for?
- Ages 60 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
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 21 May 2021to 16 Nov 2023
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 60 - 80 years
- Right handedness
Who cannot join
- Neurodegenerative neurological illnesses, epilepsy or history of seizures
- Severe and untreated medical conditions that preclude 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 to tDCS application
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-based Context
The aim of this study is to investigate whether a tDCS-accompanied intensive cognitive training is feasible as a home-based intervention.
Read the detailed description
The goal of the present study is to assess feasibility (primary) and cognitive training and transfer effects of a home-based multi-session cognitive training combined with transcranial direct current stimulation (tDCS). tDCS, particularly in combination with cognitive training, represents a promising approach to counteract cognitive decline and restore impaired functions. However, combined interventions of cognitive training and tDCS involve frequent visits to the facility, which leads to the need of space, time and personnel, and imposes strains on the participants. This study will elucidate the feasibility of tDCS and cognitive training in a home-based context. Healthy older adults will participate in a two-week cognitive training with concurrent online tDCS application in their own homes. Feasibility, as well as cognitive performance 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. A Follow-up session to assess long-term effects is planned four weeks after the post assessment. We hypothesize that with appropriate training of the participants and close supervision the use of combined tDCS and cognitive training in an ecologically valid environment by the participants themselves is feasible. In addition, we hypothesize this protocol will lead to improved performance on the trained tasks in both experimental groups. We expect increased performance on transfer tasks and long-term maintenance of the effects after anodal compared to sham stimulation. A successful implementation of the intervention in the home-based setting will contribute to the development of home-based tDCS as a widely available therapy option in clinical populations.
- Conditions
- Aging
- Being tested
- Anodal tDCS, Intensive cognitive training, Sham tDCS
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), 6 sessions with 20 minutes stimulation each (1,5 mA).
Intensive cognitive trainingBehavioural
Intensive cognitive training of a letter memory updating task, 6 sessions for approximately 20 min
Sham tDCSDevice
Sham transcranial direct current stimulation (tDCS), 6 sessions with 30 sec stimulation each (1,5 mA) to ensure blinding of participants.
| 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; Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting the intervention in a home-based context
Feasibility of home-based tDCS as operationalized by at least 2/3 (out of 6 planned sessions) successfully performed interventional sessions per participant. A session is regarded as successful if it is marked as completed in the stimulation system.
Measured: 2 weeks
Secondary outcomes (5)
Feasibility (questionnaire)
Self-rate questionnaire of participant satisfaction, independence and self-confidence in the handling of the devices and program (cf. Cha at el., 2016) after training period (anodal condition versus sham)
Measured: 2 weeks
Working memory performance at post-assessment
Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task
Measured: 2 weeks
Working memory performance at follow-up assessment
Performance in a near transfer task (n-back) under anodal tDCS compared to sham condition; operationalized by % correct responses in the n-back task
Measured: 4 weeks after intervention
Working memory training performance (Letter Updating Task) at post-assessment
Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task
Measured: 2 weeks
Working memory training performance (Letter Updating Task) at follow-up assessment
Performance in primary memory training task (Letter Updating Task) at follow-up assessment, operationalized by number of correctly recalled lists in the letter updating task
Measured: 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start21 May 2021
- Primary completion2 Oct 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnes Flöel, Prof., Study director, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817124
- Sponsor's protocol ID
- TrainStim4
- Acronym
- TrainStim4
- Status last verified
- May 2024
- First submitted
- 24 Mar 2021
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thams F, Rocke M, Malinowski R, Nowak R, Grittner U, Antonenko D, Floel A. Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-Based Context (TrainStim-Home): study protocol for a randomised controlled trial. BMJ Open. 2022 Jun 10;12(6):e059943. doi: 10.1136/bmjopen-2021-059943.
PubMed 35688585
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-based Context
- ClinicalTrials.gov ID
- NCT04817124
- Acronym / sponsor ID
- TrainStim4 / TrainStim4
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 26 Mar 2021 (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 is feasible as a home-based intervention.
Detailed description
The goal of the present study is to assess feasibility (primary) and cognitive training and transfer effects of a home-based multi-session cognitive training combined with transcranial direct current stimulation (tDCS). tDCS, particularly in combination with cognitive training, represents a promising approach to counteract cognitive decline and restore impaired functions. However, combined interventions of cognitive training and tDCS involve frequent visits to the facility, which leads to the need of space, time and personnel, and imposes strains on the participants. This study will elucidate the feasibility of tDCS and cognitive training in a home-based context. Healthy older adults will participate in a two-week cognitive training with concurrent online tDCS application in their own homes. Feasibility, as well as cognitive performance 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. A Follow-up session to assess long-term effects is planned four weeks after the post assessment. We hypothesize that with appropriate training of the participants and close supervision the use of combined tDCS and cognitive training in an ecologically valid environment by the participants themselves is feasible. In addition, we hypothesize this protocol will lead to improved performance on the trained tasks in both experimental groups. We expect increased performance on transfer tasks and long-term maintenance of the effects after anodal compared to sham stimulation. A successful implementation of the intervention in the home-based setting will contribute to the development of home-based tDCS as a widely available therapy option in clinical populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- 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 training, Device: Sham tDCSSham tDCS + intensive cognitive Training |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 60 - 80 years
- Right handedness
Key exclusion criteria (5 listed)
- Neurodegenerative neurological illnesses, epilepsy or history of seizures
- Severe and untreated medical conditions that preclude 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 to tDCS application
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), 6 sessions with 20 minutes stimulation each (1,5 mA). | Device | stimulation group |
| Intensive cognitive trainingIntensive cognitive training of a letter memory updating task, 6 sessions for approximately 20 min | Behavioural | sham group, stimulation group |
| Sham tDCSSham transcranial direct current stimulation (tDCS), 6 sessions with 30 sec stimulation each (1,5 mA) to ensure blinding of participants. | Device | sham group |
Primary outcome
Feasibility of conducting the intervention in a home-based context
Time frame: 2 weeks
Feasibility of home-based tDCS as operationalized by at least 2/3 (out of 6 planned sessions) successfully performed interventional sessions per participant. A session is regarded as successful if it is marked as completed in the stimulation system.
5 secondary outcomes
Feasibility (questionnaire)
Time frame: 2 weeks
Working memory performance at post-assessment
Time frame: 2 weeks
Working memory performance at follow-up assessment
Time frame: 4 weeks after intervention
Working memory training performance (Letter Updating Task) at post-assessment
Time frame: 2 weeks
Working memory training performance (Letter Updating Task) at follow-up assessment
Time frame: 4 weeks after intervention
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 9 May 2024.
- Derived from this study: PubMed 35688585Thams F, Rocke M, Malinowski R, Nowak R, Grittner U, Antonenko D, Floel A. Feasibility of Cognitive Training in Combination With Transcranial Direct Current Stimulation in a Home-Based Context (TrainStim-Home): study protocol for a randomised controlled trial. BMJ Open. 2022 Jun 10;12(6):e059943. doi: 10.1136/bmjopen-2021-059943.
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Aging
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 2 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 9 May 2024. 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?
Feasibility of conducting the intervention in a home-based context (time frame: 2 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 NCT04817124, which also lists 1 linked publication.
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 9 May 2024.