HealthyNCT03227185
Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Controls and Dementia Patients
A study testing real anodal transcranial direct current stimulation (tDCS) in people with Healthy and Mild Cognitive Impairment, run by University of Bern at 1 site in Switzerland.
Trial summary
Previous studies showed that anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) improved episodic memory performance, indicating a possible use as an intervention for patients suffering from memory impairments. Read more about this study
- Who is it for?
- Ages 20 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 (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2017to 19 Oct 2019
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Right-handedness
- Non-smokers
- 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
- Pregnancy
- 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: Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Young and Elderly Participants as Well as in Individuals With Memory Impairment
Previous studies showed that anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) improved episodic memory performance, indicating a possible use as an intervention for patients suffering from memory impairments. At the same time, only scant evidence (provided by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS)) exists regarding the underlying mechanisms, thus hindering a more targeted application.
The present study aims at establishing a connection between the stimulation-induced change in episodic memory performance on the behavioural level and neurophysiological parameters. TDCS effects and the underlying mechanisms will be compared between different study conditions, receiving either real anodal tDCS or sham stimulation over the left dorsolateral prefrontal cortex during an episodic memory task.
- Conditions
- Healthy, Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- real anodal transcranial direct current stimulation (tDCS), sham transcranial direct current stimulation (tDCS)
- 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 stimulation (tDCS)Device
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
sham transcranial direct current stimulation (tDCS)Device
The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
| Study group | Role | What they receive |
|---|---|---|
| Real - sham anodal tDCS | Experimental | Session 1: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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.
Session 2: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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. Receives: Device: real anodal transcranial direct current stimulation (tDCS); Device: sham transcranial direct current stimulation (tDCS) |
| Sham - real anodal tDCS | Experimental | Session 1: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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.
Session 2: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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. Receives: Device: real anodal transcranial direct current stimulation (tDCS); Device: sham transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodic memory performance - learning curve
Number of encoded words during the three consecutive immediate retrievals in the encoding phase
Measured: 0.25 hours
Episodic memory performance - delayed recall 1
Number of remembered words in the delayed recall after a short delay at the day of the on-site visit
Measured: 20 min after encoding phase
Episodic memory performance - delayed recall 2
Number of remembered words one day after learning
Measured: 1 day after on-site visit
Secondary outcomes (1)
Neurotransmitter levels
Changes in neurotransmitter levels (gamma-Aminobutyric acid (GABA) and glutamatergic metabolites (Glx) due to tDCS (comparing pre- and post-stimulation measurements in DLPFC)
Measured: 0.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Oct 2017
- Primary completion18 Oct 2019
- Study completion19 Oct 2019
Why it stopped: No patients populations included ==\> could not be recruited in meaningful numbers to allow conclusions.
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
- Model description
- Participants will be randomly assigned to two possible sequences of stimulation conditions. Group 1 will receive real tDCS stimulation to the left dlPFC during encoding on the first day and sham stimulation on the second day, and group 2 will receive sham stimulation during encoding on the first day and real tDCS on the second day. The participants will be randomized with equal probability to each of the two groups, using block randomization..
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Klöppel, Prof, Principal investigator, University Hospital of Old Age Psychiatry and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227185
- Sponsor's protocol ID
- 3351
- Other IDs
- 2016-02175, 2016
- Status last verified
- Feb 2020
- First submitted
- 19 Jul 2017
- Last updated
- 28 Feb 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 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Episodic Memory With Transcranial Direct Current Stimulation in Healthy Young and Elderly Participants as Well as in Individuals With Memory Impairment
- ClinicalTrials.gov ID
- NCT03227185
- Acronym / sponsor ID
- 3351
- Conditions
- Healthy, Mild Cognitive Impairment, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No patients populations included ==\> could not be recruited in meaningful numbers to allow conclusions.
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 19 Oct 2019 (actual)
- First posted
- 24 Jul 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 anodal tDCS applied over the dorsolateral prefrontal cortex (DLPFC) improved episodic memory performance, indicating a possible use as an intervention for patients suffering from memory impairments. At the same time, only scant evidence (provided by functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy (MRS)) exists regarding the underlying mechanisms, thus hindering a more targeted application.
The present study aims at establishing a connection between the stimulation-induced change in episodic memory performance on the behavioural level and neurophysiological parameters. TDCS effects and the underlying mechanisms will be compared between different study conditions, receiving either real anodal tDCS or sham stimulation over the left dorsolateral prefrontal cortex during an episodic memory task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to two possible sequences of stimulation conditions. Group 1 will receive real tDCS stimulation to the left dlPFC during encoding on the first day and sham stimulation on the second day, and group 2 will receive sham stimulation during encoding on the first day and real tDCS on the second day. The participants will be randomized with equal probability to each of the two groups, using block randomization..
| Arm | Type | Receives |
|---|---|---|
| Real - sham anodal tDCS | Experimental | Device: real anodal transcranial direct current stimulation (tDCS), Device: sham transcranial direct current stimulation (tDCS)Session 1: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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. Session 2: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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. |
| Sham - real anodal tDCS | Experimental | Device: real anodal transcranial direct current stimulation (tDCS), Device: sham transcranial direct current stimulation (tDCS)Session 1: 30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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. Session 2: 20 min of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Right-handedness
- Non-smokers
- Native German speakers or comparable level of fluency
- Normal or corrected-to-normal vision
Key exclusion criteria (7 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 stimulation (tDCS)The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study. | Device | Real - sham anodal tDCS, Sham - real anodal tDCS |
| sham transcranial direct current stimulation (tDCS)The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study. | Device | Real - sham anodal tDCS, Sham - real anodal tDCS |
Primary outcome
Episodic memory performance - learning curve
Time frame: 0.25 hours
Number of encoded words during the three consecutive immediate retrievals in the encoding phase
Episodic memory performance - delayed recall 1
Time frame: 20 min after encoding phase
Number of remembered words in the delayed recall after a short delay at the day of the on-site visit
Episodic memory performance - delayed recall 2
Time frame: 1 day after on-site visit
Number of remembered words one day after learning
1 secondary outcome
Neurotransmitter levels
Time frame: 0.5 hours
Results and safety
The study was stopped early (reason given: No patients populations included ==\> could not be recruited in meaningful numbers to allow conclusions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 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 principal investigator
University Hospital of Old Age Psychiatry and Psychotherapy
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 (tDCS) 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 7 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: stopped early, as of the sponsor's last update on 28 Feb 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. 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 was stopped early (reason given: No patients populations included ==\> could not be recruited in meaningful numbers to allow conclusions.). Results are not available in the source record.
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?
Episodic memory performance - learning curve (time frame: 0.25 hours). 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 28 Feb 2020.