Clinical trial NCT02092974: Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin
Official title: Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Young and Older Adults
Keywords: transcranial direct current stimulation (tDCS)
selective serotonin reuptake inhibitor (SSRI)
young
older adults
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Recall score after learning under tDC stimulation + SSRI compared to learning under tDC stimulation + placebo.
timeFrame: immediately after end of learning phase (approx. 1 hour)
Secondary outcomes:
measure: prolongation of the atDCS induced learning enhancement by SSRI
timeFrame: 1 week
measure: Increase of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo
timeFrame: immediately after learning phase (approx. 1 hour)
measure: prolongation of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo
timeFrame: 1 week
measure: genotyping of learning related polymorphisms
timeFrame: once
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.