Genetic PredispositionACTTDCS-FGNCT06402266
Simultaneous tDCS and Computerised Gamified Short-term Memory Task Feasibility
An observational study of Genetic Predisposition, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this observational study is to gain insight into the effects of transcranial direct current stimulation (tDCS) on short-term memory task performance and the feasibility of tDCS in overtly healthy carriers of the susceptibility allele, Apolipoprotein (APOE) ε4, for late-onset Alzheimers disease. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition
- What is being tested?
- tDCS
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jul 2022to 23 Nov 2023
- Phase
- Observational
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of healthy elderly APOE ε4 carriers recruited from an existing, in-house registry.
Who may be able to join
- Age range: 55-75 years old
- The participant is confirmed to carry at least one APOE ε4 allele on a blood test
- The participant has at least 7 years of education or a good working history
- Normal cognition (MMSE score > 26)
Who cannot join
- Any dementia
- Significant systematic disease
- Severe and unstable medical disease or psychiatric disorder, including medications for these diseases or disorders
- Past history of stroke or brain damage
- Epilepsy or history of epileptic seizures
- Migraine
Show all 12Show fewer
- Skin or scalp condition in the areas where the electrodes will be placed
- Depression
- Alcohol or drug abuse
- Significantly impaired vision or hearing
- Colour blindness
- Adverse effects to previous tDCS or other brain stimulation techniques
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Centre for Functionally Integrative Neuroscience
Aarhus, Aarhus N, 8200
About this study
Official title: Effects of Transcranial Direct Current Brain Stimulation on Apolipoprotein-ε4 Allele Gene Carriers on an App-based Short-term Memory Task
The goal of this observational study is to gain insight into the effects of transcranial direct current stimulation (tDCS) on short-term memory task performance and the feasibility of tDCS in overtly healthy carriers of the susceptibility allele, Apolipoprotein (APOE) ε4, for late-onset Alzheimers disease.
The main questions the study aims to answer are:
Read more
- If tDCS is feasible in overtly healthy APOE ε4 carriers using a headset and an app-based short-term memory task.
- If overtly healthy APOE ε4 carriers perform better on a complex short-term memory task when receiving tDCS to the right hemisphere (F4 à PZ) compared to the left hemisphere (F3 à PZ) or sham tDCS.
Participants will be asked to complete an app-based short-term memory task while receiving either tDCS to either the right or left hemisphere or sham stimulation on 3 different days spread out over 1-3 weeks.
Read the detailed description
Alzheimer's disease (AD) is the most common neurodegenerative disorder causing dementia. The most common form of AD is that of idiopathic AD, or late-onset AD, which typically affects individuals above the age of 65. Individuals, who are carriers of the Apolipoprotein (APOE) ε4 allele have an increased risk of developing late-onset AD, and AD brain pathology has been observed in APOE ε4 carriers as young as 55 years of age.
AD can be perceived as a continuum, with the pathophysiological disease process beginning in the brain many years prior to the onset of overt symptoms. Thus, individuals may show evidence of AD biomarkers in blood or cerebrospinal fluid or on brain scans in the absence of any overt symptoms. Individuals with incipient AD brain pathology but no overt symptoms may be classified as 'preclinical AD'. APOE ε4 allele carriage increases the risk of developing AD brain pathology 2-4 fold.
One of the most common cognitive symptoms in AD is memory impairment, such as impairments in short-term memory (STM). Subtle impairments in memory, including in STM, can even be detected in preclinical AD using sensitive memory tests. Therefore, STM may provide a suitable target to help preserve individual's cognitive functioning earlier in the disease process.
Cognitive reserve is a hypothetical construct proposed to explain the incongruency between the burden of AD pathology and cognitive dysfunction observed in some older individuals and has been defined as the ability to optimise or maximise performance through differential recruitment of brain networks. Epidemiological studies suggest that the cognitive reserve is increased by lifetime exposures, including educational and occupational attainment as well as leisure activities in late life. An underlying assumption is that these exposures improve brain plasticity. Cognitive training has shown positive effects with regards to promoting brain plasticity in older adults and could thus have the potential to foster or strengthen cognitive reserve in individuals at risk for developing AD later in life.
Cognitive training in combination with other neuroplasticity-enhancing techniques has been suggested as an option for promoting the positive effects of cognitive training alone. Transcranial direct current stimulation (tDCS) is a noninvasive neuro-modulatory technique where low intensity direct current is delivered to cortical areas to facilitate or inhibit ongoing, spontaneous neuronal activity. As tDCS has been shown to improve STM in healthy elderly participants, combining cognitive training with tDCS may be a way to enhance the effects of cognitive training and enhance cognitive reserve. Thus, it is sensible to explore the feasibility of tDCS on improving STM during a computerised game targeting STM, starting with healthy elderly APOE ε4 allele carriers, i.e. healthy elderly individuals, who are genetically predispositioned to AD, but who are otherwise healthy.
This study aims to investigate the effect of tDCS on memory performance on an app-based STM task in healthy elderly APOE ε4 carriers aged 55-75. All participants will be recruited from an existing in-house registry of individuals who have already been confirmed to be APOE ε4 carriers on a blood test. The tDCS or sham stimulation will be delivered by a headseat, where the spatial arrangement of the electrodes that delivers the stimulation and their outlets used in the stimulation determines the regions and distributed networks of the brain being stimulated. Participants will first try out the app-based STM task on its own in order to become familiar with it. Thereafter, they will come in on 3 different days within 1-3 weeks, where they will complete the same STM task again while undergoing either active or sham tDCS. This will allow for the examination of whether active tDCS can improve memory performance on this type of complex STM task in overall healthy elderly individuals who are genetically predisposed for late-onset AD.
- Conditions
- Genetic Predisposition
- Being tested
- tDCS
- Keywords
- Apolipoprotein E4, Cognitive reserve, Gamified cognitive training, Brain stimulation, tDCS, Technical compatibility
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
The STM task will be combined with respectively two times active tDCS and one sham tDCS. The 3 conditions will be randomised, and both scientific staff and participants will be blinded.
Participants will perform the STM task on a tablet for 45 min. Headsets will deliver the tDCS. Two different placements will be used for the active stimulations: 1) F3 and PZ, and 2) F4 and PZ. The current output range will be 1.6mA and the stimulation will last for 30 min. The sham stimulation will function as a control condition. During the sham stimulation, the current density will be ramped up for 15 sec until the current reaches a density of 1.6mA for 60 sec and then again ramped down for 15 sec.
After the session, participants will fill out a brief questionnaire regarding their experience.
The time interval between sessions will be 1-3 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
Observations of the feasibility of simultaneous tDCS with a computerised, gamified short-term memory task
The first outcome measure has to do with whether it is feasible to deliver tDCS via a portable headset while participants perform a computerised gamified STM task, in order to evaluate whether this would be possible in a home-based setting. This will be measured is by observing the sessions with this set-up and noting down difficulties during the session, including technical challenges and participant complaints.
Measured: During stimulation (up to 1 hour)
Participants' self-reported experience of the simultaneous tDCS with a computerised, gamified short-term memory task assessed by a self-report questionnaire
The second outcome measure has to do with how the participants experienced the session. This will be assessed by having participants answer a self-report questionnaire on their experience after the session. The questionnaire consists of 3 overarching questions: 1) how the participants felt wearing the head-set; 2) how they experienced the stimulation, including whether they felt any discomfort; and 3) and how they experienced the overall set-up with the headset and the gamified STM task, including their assessment on whether they think it will work in a home-based setting.
Measured: Post-stimulation (through study completion, up to 1 year)
Effects of tDCS on computerised gamified short-term memory task performance
The third outcome measure has to do with whether simultaneous brain stimulation affects participants' performance on the gamified STM task; or, more specifically, whether participants receiving tDCS stimulation performed better than those receiving sham stimulation. This is done by automatically logging the task data, which can then be accessed after the session. The outcome is evaluated as one overall score of STM performance based upon 1) identification accuracy, and 2) placement accuracy. A higher overall STM performance score indicates better performance.
Measured: Post-stimulation (through study completion, up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start4 Jul 2022
- Primary completion12 Dec 2022
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic PredispositionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Brain+ ApS, Eurostars EUREKA, Innovation Fund Denmark
- Responsible party
- Sponsor
- Investigators
- Jakob U Blicher, Assoc. Prof., Principal investigator, Aarhus University, Centre for Functionally Integrative Neuroscience (CFIN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402266
- Sponsor's protocol ID
- ACTTDCS
- Acronym
- ACTTDCS-FG
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 7 May 2024
- 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 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Brain Stimulation on Apolipoprotein-ε4 Allele Gene Carriers on an App-based Short-term Memory Task
- ClinicalTrials.gov ID
- NCT06402266
- Acronym / sponsor ID
- ACTTDCS-FG / ACTTDCS
- Conditions
- Genetic Predisposition
- Keywords
- Apolipoprotein E4, Cognitive reserve, Gamified cognitive training, Brain stimulation, tDCS, Technical compatibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Brain+ ApS, Eurostars EUREKA, Innovation Fund Denmark
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 7 May 2024 (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 goal of this observational study is to gain insight into the effects of transcranial direct current stimulation (tDCS) on short-term memory task performance and the feasibility of tDCS in overtly healthy carriers of the susceptibility allele, Apolipoprotein (APOE) ε4, for late-onset Alzheimers disease.
The main questions the study aims to answer are:
- If tDCS is feasible in overtly healthy APOE ε4 carriers using a headset and an app-based short-term memory task.
- If overtly healthy APOE ε4 carriers perform better on a complex short-term memory task when receiving tDCS to the right hemisphere (F4 à PZ) compared to the left hemisphere (F3 à PZ) or sham tDCS.
Participants will be asked to complete an app-based short-term memory task while receiving either tDCS to either the right or left hemisphere or sham stimulation on 3 different days spread out over 1-3 weeks.
Detailed description
Alzheimer's disease (AD) is the most common neurodegenerative disorder causing dementia. The most common form of AD is that of idiopathic AD, or late-onset AD, which typically affects individuals above the age of 65. Individuals, who are carriers of the Apolipoprotein (APOE) ε4 allele have an increased risk of developing late-onset AD, and AD brain pathology has been observed in APOE ε4 carriers as young as 55 years of age.
AD can be perceived as a continuum, with the pathophysiological disease process beginning in the brain many years prior to the onset of overt symptoms. Thus, individuals may show evidence of AD biomarkers in blood or cerebrospinal fluid or on brain scans in the absence of any overt symptoms. Individuals with incipient AD brain pathology but no overt symptoms may be classified as 'preclinical AD'. APOE ε4 allele carriage increases the risk of developing AD brain pathology 2-4 fold.
One of the most common cognitive symptoms in AD is memory impairment, such as impairments in short-term memory (STM). Subtle impairments in memory, including in STM, can even be detected in preclinical AD using sensitive memory tests. Therefore, STM may provide a suitable target to help preserve individual's cognitive functioning earlier in the disease process.
Cognitive reserve is a hypothetical construct proposed to explain the incongruency between the burden of AD pathology and cognitive dysfunction observed in some older individuals and has been defined as the ability to optimise or maximise performance through differential recruitment of brain networks. Epidemiological studies suggest that the cognitive reserve is increased by lifetime exposures, including educational and occupational attainment as well as leisure activities in late life. An underlying assumption is that these exposures improve brain plasticity. Cognitive training has shown positive effects with regards to promoting brain plasticity in older adults and could thus have the potential to foster or strengthen cognitive reserve in individuals at risk for developing AD later in life.
Cognitive training in combination with other neuroplasticity-enhancing techniques has been suggested as an option for promoting the positive effects of cognitive training alone. Transcranial direct current stimulation (tDCS) is a noninvasive neuro-modulatory technique where low intensity direct current is delivered to cortical areas to facilitate or inhibit ongoing, spontaneous neuronal activity. As tDCS has been shown to improve STM in healthy elderly participants, combining cognitive training with tDCS may be a way to enhance the effects of cognitive training and enhance cognitive reserve. Thus, it is sensible to explore the feasibility of tDCS on improving STM during a computerised game targeting STM, starting with healthy elderly APOE ε4 allele carriers, i.e. healthy elderly individuals, who are genetically predispositioned to AD, but who are otherwise healthy.
This study aims to investigate the effect of tDCS on memory performance on an app-based STM task in healthy elderly APOE ε4 carriers aged 55-75. All participants will be recruited from an existing in-house registry of individuals who have already been confirmed to be APOE ε4 carriers on a blood test. The tDCS or sham stimulation will be delivered by a headseat, where the spatial arrangement of the electrodes that delivers the stimulation and their outlets used in the stimulation determines the regions and distributed networks of the brain being stimulated. Participants will first try out the app-based STM task on its own in order to become familiar with it. Thereafter, they will come in on 3 different days within 1-3 weeks, where they will complete the same STM task again while undergoing either active or sham tDCS. This will allow for the examination of whether active tDCS can improve memory performance on this type of complex STM task in overall healthy elderly individuals who are genetically predisposed for late-onset AD.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of healthy elderly APOE ε4 carriers recruited from an existing, in-house registry.
Key inclusion criteria (4 listed)
- Age range: 55-75 years old
- The participant is confirmed to carry at least one APOE ε4 allele on a blood test
- The participant has at least 7 years of education or a good working history
- Normal cognition (MMSE score > 26)
Key exclusion criteria (12 listed)
- Any dementia
- Significant systematic disease
- Severe and unstable medical disease or psychiatric disorder, including medications for these diseases or disorders
- Past history of stroke or brain damage
- Epilepsy or history of epileptic seizures
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 |
|---|---|---|
| tDCSThe STM task will be combined with respectively two times active tDCS and one sham tDCS. The 3 conditions will be randomised, and both scientific staff and participants will be blinded. Participants will perform the STM task on a tablet for 45 min. Headsets will deliver the tDCS. Two different placements will be used for the active stimulations: 1) F3 and PZ, and 2) F4 and PZ. The current output range will be 1.6mA and the stimulation will last for 30 min. The sham stimulation will function as a control condition. During the sham stimulation, the current density will be ramped up for 15 sec until the current reaches a density of 1.6mA for 60 sec and then again ramped down for 15 sec. After the session, participants will fill out a brief questionnaire regarding their experience. The time interval between sessions will be 1-3 weeks. | Device | – |
Primary outcome
Observations of the feasibility of simultaneous tDCS with a computerised, gamified short-term memory task
Time frame: During stimulation (up to 1 hour)
The first outcome measure has to do with whether it is feasible to deliver tDCS via a portable headset while participants perform a computerised gamified STM task, in order to evaluate whether this would be possible in a home-based setting. This will be measured is by observing the sessions with this set-up and noting down difficulties during the session, including technical challenges and participant complaints.
Participants' self-reported experience of the simultaneous tDCS with a computerised, gamified short-term memory task assessed by a self-report questionnaire
Time frame: Post-stimulation (through study completion, up to 1 year)
The second outcome measure has to do with how the participants experienced the session. This will be assessed by having participants answer a self-report questionnaire on their experience after the session. The questionnaire consists of 3 overarching questions: 1) how the participants felt wearing the head-set; 2) how they experienced the stimulation, including whether they felt any discomfort; and 3) and how they experienced the overall set-up with the headset and the gamified STM task, including their assessment on whether they think it will work in a home-based setting.
Effects of tDCS on computerised gamified short-term memory task performance
Time frame: Post-stimulation (through study completion, up to 1 year)
The third outcome measure has to do with whether simultaneous brain stimulation affects participants' performance on the gamified STM task; or, more specifically, whether participants receiving tDCS stimulation performed better than those receiving sham stimulation. This is done by automatically logging the task data, which can then be accessed after the session. The outcome is evaluated as one overall score of STM performance based upon 1) identification accuracy, and 2) placement accuracy. A higher overall STM performance score indicates better performance.
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 2024.
- 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.
Jakob U Blicher, Assoc. Prof. principal investigator
Aarhus University, Centre for Functionally Integrative Neuroscience (CFIN)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Predisposition, run by University of Aarhus at 1 site in Denmark.
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 12 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 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 Denmark. 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. 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?
Observations of the feasibility of simultaneous tDCS with a computerised, gamified short-term memory task (time frame: During stimulation (up to 1 hour)). 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?
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 2024.