Healthy Young and Older AdultsPhase 1LESONCT02092974
Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin
A Phase 1 study testing tDCS and Citalopram in people with Healthy Young and Older Adults, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this study is to assess whether the application of a selective serotonin reuptake inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal transcranial direct current stimulation (atDCS). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young and Older Adults
- What is being tested?
- tDCS and Citalopram
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Dec 2014
- Phase
- Phase 1
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- right handedness
- unobtrusive neuropsychological screening
- ability to provide written informed consent
- no pathological findings in head MRI
- age: 18 to 35 years (young adults) or 50-80 years (older adults)
- Highly effective contraception (Pearl Index < 1) or reliable abstinence from any heterosexual relationships in women of childbearing potential
Who cannot join
- severe internal or psychiatric disease (especially depression or suicidal thoughts)
- epilepsy
- cognitive impairment (< SD under age adjusted norm in neuropsychological testing)
- concurrent taking of serotonin precursors (tryptophan, 5-HTP) or MAO inhibitors
- concurrent taking of tramadol or triptans
- concurrent taking of pimozide or linezolid
Show all 15Show fewer
- concurrent taking of other drugs prolonging the QT-interval
- long-QT-syndrome
- hypokalemia or hypomagnesemia
- known intolerance of the study medication
- claustrophobia or metallic implants, tattoos (MRI exclusion criteria)
- pregnancy or lactation
- participation in another drug-interventional clinical trial within the last month or during the entire study
- probands that are placed in an institution due to official or judicial order
- non-agreement to save and transmit pseudonymised study data within the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to assess whether the application of a selective serotonin reuptake inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal transcranial direct current stimulation (atDCS). For this, young and older healthy subjects will be tested with a well established learning paradigm. Results of this study may help to support the application of atDCS also in patients, e.g. with dementia or mild cognitive impairment.
- Conditions
- Healthy Young and Older Adults
- Being tested
- tDCS, Citalopram, sham-tDCS + placebo
- Keywords
- transcranial direct current stimulation (tDCS), selective serotonin reuptake inhibitor (SSRI), young, older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSProcedure or surgery
Also called transcranial direct current stimulation
CitalopramDrug
Also called SSRI
sham-tDCS + placeboOther
| Study group | Role | What they receive |
|---|---|---|
| tDCS + SSRI | Experimental | Not described Receives: Procedure: tDCS; Drug: Citalopram |
| tDCS + placebo | Placebo comparator | Not described Receives: Procedure: tDCS |
| sham-tDCS + SSRI | Sham comparator | Not described Receives: Drug: Citalopram |
| sham-DCS + placebo | Placebo comparator | Not described Receives: Other: sham-tDCS + placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall score after learning under tDC stimulation + SSRI compared to learning under tDC stimulation + placebo.
Recall score immediately after learning phase (=training of visual-spatial abilities) under tDC stimulation + SSRI application compared to learning under tDC stimulation + placebo.
Measured: immediately after end of learning phase (approx. 1 hour)
Secondary outcomes (4)
prolongation of the atDCS induced learning enhancement by SSRI
Measurement of recall scores on the evening of the same day after the learning phase (+tDCS + SSRI), the morning of the day after and 1 week later in order to assess the prolongation of atDCS induced learning enhancement by the SSRI.
Measured: 1 week
Increase of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo
Measurement of recall scores directly after learning phase after application of atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo.
Measured: immediately after learning phase (approx. 1 hour)
prolongation of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo
Measurement of recall scores on the evening of the same day of learning phase, the morning of the day after and 1 week later under application of atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo, in order to assess prolongation of learning enhancement by SSRI.
Measured: 1 week
genotyping of learning related polymorphisms
To assess predictors of SSRI-enhanced brain stimulation, genotyping of several learning related polymorphisms will be performed (i.e., APOE, BDNF, Val66Met, COMT, Val158Met, KIBRA, rs17070145, 5-Hydroxytryptamine transporter).
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
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 Healthy Young and Older AdultsStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Flöel, Charite University, Berlin, Germany
- Investigators
- Agnes Flöel, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092974
- Sponsor's protocol ID
- LESO
- Acronym
- LESO
- Status last verified
- May 2021
- First submitted
- 19 Mar 2014
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Prehn K, Stengl H, Grittner U, Kosiolek R, Olschlager A, Weidemann A, Floel A. Effects of Anodal Transcranial Direct Current Stimulation and Serotonergic Enhancement on Memory Performance in Young and Older Adults. Neuropsychopharmacology. 2017 Jan;42(2):551-561. doi: 10.1038/npp.2016.170. Epub 2016 Aug 24.
PubMed 27555381
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin
- ClinicalTrials.gov ID
- NCT02092974
- Acronym / sponsor ID
- LESO / LESO
- Conditions
- Healthy Young and Older Adults
- Keywords
- transcranial direct current stimulation (tDCS), selective serotonin reuptake inhibitor (SSRI), young, older adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Mar 2014 (estimated)
- 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 assess whether the application of a selective serotonin reuptake inhibitor (SSRI) enhances and prolongs the learning enhancement achieved by anodal transcranial direct current stimulation (atDCS). For this, young and older healthy subjects will be tested with a well established learning paradigm. Results of this study may help to support the application of atDCS also in patients, e.g. with dementia or mild cognitive impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS + SSRI | Experimental | Procedure: tDCS, Drug: Citalopram |
| tDCS + placebo | Placebo comparator | Procedure: tDCS |
| sham-tDCS + SSRI | Sham comparator | Drug: Citalopram |
| sham-DCS + placebo | Placebo comparator | Other: sham-tDCS + placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- right handedness
- unobtrusive neuropsychological screening
- ability to provide written informed consent
- no pathological findings in head MRI
- age: 18 to 35 years (young adults) or 50-80 years (older adults)
Key exclusion criteria (15 listed)
- severe internal or psychiatric disease (especially depression or suicidal thoughts)
- epilepsy
- cognitive impairment (< SD under age adjusted norm in neuropsychological testing)
- concurrent taking of serotonin precursors (tryptophan, 5-HTP) or MAO inhibitors
- concurrent taking of tramadol or triptans
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 |
|---|---|---|
| tDCSAlso: transcranial direct current stimulation | Procedure or surgery | tDCS + SSRI, tDCS + placebo |
| CitalopramAlso: SSRI | Drug | sham-tDCS + SSRI, tDCS + SSRI |
| sham-tDCS + placebo | Other | sham-DCS + placebo |
Primary outcome
Recall score after learning under tDC stimulation + SSRI compared to learning under tDC stimulation + placebo.
Time frame: immediately after end of learning phase (approx. 1 hour)
Recall score immediately after learning phase (=training of visual-spatial abilities) under tDC stimulation + SSRI application compared to learning under tDC stimulation + placebo.
4 secondary outcomes
prolongation of the atDCS induced learning enhancement by SSRI
Time frame: 1 week
Increase of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo
Time frame: immediately after learning phase (approx. 1 hour)
prolongation of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo
Time frame: 1 week
genotyping of learning related polymorphisms
Time frame: once
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 12 May 2021.
- Results publication: PubMed 27555381Prehn K, Stengl H, Grittner U, Kosiolek R, Olschlager A, Weidemann A, Floel A. Effects of Anodal Transcranial Direct Current Stimulation and Serotonergic Enhancement on Memory Performance in Young and Older Adults. Neuropsychopharmacology. 2017 Jan;42(2):551-561. doi: 10.1038/npp.2016.170. Epub 2016 Aug 24.
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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. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tDCS and Citalopram in people with Healthy Young and Older Adults, run by Charite University, Berlin, Germany 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 6 inclusion and 15 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 12 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recall score after learning under tDC stimulation + SSRI compared to learning under tDC stimulation + placebo. (time frame: immediately after end of learning phase (approx. 1 hour)). 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 NCT02092974, 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 12 May 2021.