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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT02092974

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Young and Older Adults	Procedure: tDCS Drug: Citalopram Other: sham-tDCS + placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tDCS + SSRI	Procedure: tDCS Other Names: transcranial direct current stimulation Drug: Citalopram Other Names: SSRI
Placebo Comparator: tDCS + placebo	Procedure: tDCS Other Names: transcranial direct current stimulation
Sham Comparator: sham-tDCS + SSRI	Drug: Citalopram Other Names: SSRI
Placebo Comparator: sham-DCS + placebo	Other: sham-tDCS + placebo

Outcome Measures

Primary Outcome Measures

Recall score after learning under tDC stimulation + SSRI compared to learning under tDC stimulation + placebo. [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 Outcome Measures

prolongation of the atDCS induced learning enhancement by SSRI [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 [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 [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

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)
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charite Universitätsmedizin Berlin	Berlin		Germany	10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT02092974

Other Study ID Numbers:

LESO

First Posted:

Mar 20, 2014

Last Update Posted:

May 12, 2021

Last Verified:

May 1, 2021

Keywords provided by Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany

transcranial direct current stimulation (tDCS)

selective serotonin reuptake inhibitor (SSRI)

young

older adults

Additional relevant MeSH terms:

Citalopram

Study Results

No Results Posted as of May 12, 2021