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

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ClinicalTrials.gov Identifier: NCT02092974
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

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 Type : Interventional  (Clinical Trial)
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 : April 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Arm Intervention/treatment
Experimental: tDCS + SSRI Procedure: tDCS
Other Name: transcranial direct current stimulation

Drug: Citalopram
Other Name: SSRI

Placebo Comparator: tDCS + placebo Procedure: tDCS
Other Name: transcranial direct current stimulation

Sham Comparator: sham-tDCS + SSRI Drug: Citalopram
Other Name: SSRI

Placebo Comparator: sham-DCS + placebo Other: sham-tDCS + placebo



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092974


Locations
Germany
Charite Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Agnes Flöel, Prof. Dr. Charite University, Berlin, Germany

Publications:
Responsible Party: Agnes Flöel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02092974     History of Changes
Other Study ID Numbers: LESO
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

Keywords provided by Agnes Flöel, Charite University, Berlin, Germany:
transcranial direct current stimulation (tDCS)
selective serotonin reuptake inhibitor (SSRI)
young
older adults

Additional relevant MeSH terms:
Serotonin
Citalopram
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs