Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Recall score after learning under tDC stimulation + SSRI compared to learning under tDC stimulation + placebo.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
- •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
Arms & Interventions
tDCS + SSRI
Intervention: tDCS (Procedure)
tDCS + SSRI
Intervention: Citalopram (Drug)
tDCS + placebo
Intervention: tDCS (Procedure)
sham-tDCS + SSRI
Intervention: Citalopram (Drug)
sham-DCS + placebo
Intervention: sham-tDCS + placebo (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- prolongation of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo(1 week)
- prolongation of the atDCS induced learning enhancement by SSRI(1 week)
- Increase of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo(immediately after learning phase (approx. 1 hour))
- genotyping of learning related polymorphisms(once)
Investigators
Agnes Flöel
Prof. Dr.
Charite University, Berlin, Germany