Mechanism of tDCS-induced Learning Enhancement - the Role of Serotonin (LESO)

May 10, 2021 updated by: Agnes Flöel, Charite University, Berlin, Germany
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS + SSRI
Drug: Citalopram
Other Names:
  • SSRI
Procedure: tDCS
Other Names:
  • transcranial direct current stimulation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediately after end of learning phase (approx. 1 hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
Measurement of recall scores directly after learning phase after application of atDCS + placebo or sham-tDCS + SSRI vs. sham-tDCS + placebo.
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
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.
1 week
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).
once

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 19, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LESO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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