Completed

NCT Number: NCT02092974

Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin

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.

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Key information

Conditions

Healthy Young and Older Adults

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charite Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Procedure

Other names: transcranial direct current stimulation

Citalopram

Drug

Other names: SSRI

sham-tDCS + placebo

Other

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 the atDCS induced learning enhancement by SSRI

Time frame: 1 week

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.
Increase of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo

Time frame: immediately after learning phase (approx. 1 hour)

Measurement of recall scores directly after learning phase after application of atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo.
prolongation of learning enhancement by atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo

Time frame: 1 week

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.
genotyping of learning related polymorphisms

Time frame: once

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).

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: LESO

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Mar 20, 2014
Registry last updated: May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.