HealthyNCT03351452
tES Effects on Associative Memory Performance
A study testing real anodal transcranial direct current stimulation and real transcranial alternating current stimulation in people with Healthy and Mild Cognitive Impairment, run by University of Bern at 1 site in Switzerland.
Trial summary
Previous studies showed that transcranial electric stimulation (tES) applied over the prefrontal cortex improves cognitive performance in healthy elderly adults as well as in patients suffering from mild cognitive impairment or early Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- real anodal transcranial direct current stimulation and real transcranial alternating current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Apr 2018to 24 Feb 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Non-smokers
- Right-handedness
- Native German speakers or comparable level of fluency
- Normal or corrected-to-normal vision
Who cannot join
- Neurological or psychiatric condition (other than diagnosed cognitive impairment)
- Past head injuries
- Magnetizable implants
- History of seizures
- Current or life-time alcohol or drug abuse
- Skin diseases
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Old Age Psychiatry and Psychotherapy
Bern, 3000
About this study
Official title: Effects of Transcranial Electric Stimulation on Associative Memory Formation in Healthy Elderly Participants as Well as in Individuals With Memory Impairment
Previous studies showed that transcranial electric stimulation (tES) applied over the prefrontal cortex improves cognitive performance in healthy elderly adults as well as in patients suffering from mild cognitive impairment or early Alzheimer's disease. Therefore, tES methods might be a useful intervention tool for patients suffering from memory impairment in early terms of the disease.
The present study aims at establishing a connection between the stimulation-induced changes on associative memory performance and its underlying neurophysiological parameters. tES effects and their underlying mechanisms will be compared between healthy elderly controls and clinical study populations receiving either real or sham tES over the left ventrolateral prefrontal cortex during an associative memory task.
- Conditions
- Healthy, Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- real anodal transcranial direct current stimulation, real transcranial alternating current stimulation, sham transcranial electric current stimulation
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real anodal transcranial direct current stimulationDevice
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
real transcranial alternating current stimulationDevice
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
sham transcranial electric current stimulationDevice
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Experimental | 20 min of 2 mA real anodal transcranial direct current stimulation applied via 5x7 cm rubber electrode over the VLPFC (current density: 0.057 mA/cm2) and cathodal 10x10 rubber electrode over supraorbital region (current density: 0.02 mA/cm2). Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation. Receives: Device: real anodal transcranial direct current stimulation |
| Real tACS | Experimental | 20 min of 2 mA real transcranial alternating current stimulation in theta frequency applied via 5x7 cm and 10x10 cm rubber electrodes over the VLPFC (current density: 0.057 mA/cm2) and supraorbital region (current density: 0.02 mA/cm2). Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation. Receives: Device: real transcranial alternating current stimulation |
| Sham tES | Sham comparator | 30 s of 2 mA sham transcranial electric current stimulation applied via 5x7 cm and 10x10 cm rubber electrodes over the VLPFC (current density: 0.057 mA/cm2) and supraorbital region (current density: 0.02 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase of the memory task. Receives: Device: sham transcranial electric current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on immediate cued recall task
Number of correct responses on retrieval task of previously learned associative memory items
Measured: 20 min
Performance on delayed cued recall task
Number of correct responses on retrieval task of previously learned associative memory items
Measured: 24 hours
Secondary outcomes (2)
task-dependent BOLD activity
Measured with functional magnetic resonance imaging (fMRI)
Measured: 20 min
resting-state BOLD activity
Measured with functional magnetic resonance imaging (fMRI)
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start9 Apr 2018
- Primary completion30 Sep 2018
- Study completion24 Feb 2020
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Klöppel, Prof.Dr.med, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351452
- Sponsor's protocol ID
- 2017-01197
- Other IDs
- 2017
- Status last verified
- Mar 2020
- First submitted
- 14 Nov 2017
- Last updated
- 13 Mar 2020
- Results posted
- 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 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Electric Stimulation on Associative Memory Formation in Healthy Elderly Participants as Well as in Individuals With Memory Impairment
- ClinicalTrials.gov ID
- NCT03351452
- Acronym / sponsor ID
- 2017-01197
- Conditions
- Healthy, Mild Cognitive Impairment, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 22 Nov 2017 (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.
Previous studies showed that transcranial electric stimulation (tES) applied over the prefrontal cortex improves cognitive performance in healthy elderly adults as well as in patients suffering from mild cognitive impairment or early Alzheimer's disease. Therefore, tES methods might be a useful intervention tool for patients suffering from memory impairment in early terms of the disease.
The present study aims at establishing a connection between the stimulation-induced changes on associative memory performance and its underlying neurophysiological parameters. tES effects and their underlying mechanisms will be compared between healthy elderly controls and clinical study populations receiving either real or sham tES over the left ventrolateral prefrontal cortex during an associative memory task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Device: real anodal transcranial direct current stimulation20 min of 2 mA real anodal transcranial direct current stimulation applied via 5x7 cm rubber electrode over the VLPFC (current density: 0.057 mA/cm2) and cathodal 10x10 rubber electrode over supraorbital region (current density: 0.02 mA/cm2). Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation. |
| Real tACS | Experimental | Device: real transcranial alternating current stimulation20 min of 2 mA real transcranial alternating current stimulation in theta frequency applied via 5x7 cm and 10x10 cm rubber electrodes over the VLPFC (current density: 0.057 mA/cm2) and supraorbital region (current density: 0.02 mA/cm2). Additional ramp-up and ramp-down phase of 15 s at the beginning and the end of stimulation. |
| Sham tES | Sham comparator | Device: sham transcranial electric current stimulation30 s of 2 mA sham transcranial electric current stimulation applied via 5x7 cm and 10x10 cm rubber electrodes over the VLPFC (current density: 0.057 mA/cm2) and supraorbital region (current density: 0.02 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase of the memory task. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Non-smokers
- Right-handedness
- Native German speakers or comparable level of fluency
- Normal or corrected-to-normal vision
Key exclusion criteria (6 listed)
- Neurological or psychiatric condition (other than diagnosed cognitive impairment)
- Past head injuries
- Magnetizable implants
- History of seizures
- Current or life-time alcohol or drug abuse
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 |
|---|---|---|
| real anodal transcranial direct current stimulationThe MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used. | Device | Real tDCS |
| real transcranial alternating current stimulationThe MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used. | Device | Real tACS |
| sham transcranial electric current stimulationThe MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used. | Device | Sham tES |
Primary outcome
Performance on immediate cued recall task
Time frame: 20 min
Number of correct responses on retrieval task of previously learned associative memory items
Performance on delayed cued recall task
Time frame: 24 hours
Number of correct responses on retrieval task of previously learned associative memory items
2 secondary outcomes
task-dependent BOLD activity
Time frame: 20 min
resting-state BOLD activity
Time frame: 10 min
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 13 Mar 2020.
- 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.
Stefan Klöppel, Prof.Dr.med principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real anodal transcranial direct current stimulation and real transcranial alternating current stimulation in people with Healthy and Mild Cognitive Impairment, run by University of Bern at 1 site in Switzerland.
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 5 inclusion and 6 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 13 Mar 2020. 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 Switzerland. 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 on immediate cued recall task (time frame: 20 min). The study lists 2 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 13 Mar 2020.