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Supporting Incidental Learning With Transcranial Direct Current Stimulation in Healthy Young and Elderly Individuals

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ClinicalTrials.gov Identifier: NCT03959462
Recruitment Status : Active, not recruiting
First Posted : May 22, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of Bern

Brief Summary:
Incidental learning happens without any deliberate intention to memorize. Experimental manipulations of incidental learning typically involves prompting individuals to solve a categorical decision task, followed by an unexpected free recall of the presented stimuli. According to the level of processing framework, deep encoding of the stimuli will lead to a stronger memory trace and thus, better recall. Deep encoding means that individuals focus on the meaning of stimuli rather than their appearance. On the neuronal level, the dorsolateral prefrontal cortex (dlPFC) is important for both encoding and recall as well as during the evaluation of emotional content. Transcranial direct current stimulation (tDCS) applied with the aim to increase dlPFC activity may, therefore, help to improve recall performance as well as modulate the evaluation of emotional content.

Condition or disease Intervention/treatment Phase
Real tDCS Sham tDCS Device: real anodal transcranial direct current stimulation Device: sham transcranial direct current stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are allocated to one of 2 groups: real tDCS or sham.
Masking: Double (Participant, Investigator)
Masking Description: Double blind design
Primary Purpose: Basic Science
Official Title: Supporting Incidental Learning With Transcranial Direct Current Stimulation in Healthy Young and Elderly Individuals
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Real tDCS
20 min of 1 mA real anodal transcranial direct current stimulation applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase.
Device: real anodal transcranial direct current stimulation
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.

Sham Comparator: Sham tDCS
30 s of 1 mA anodal tDCS applied via 5x7 cm rubber electrodes over the DLPFC (current density: 0.028 mA/cm2). Additional ramp-up and ramp-down phase at beginning and end of stimulation lasting for 15 s. Electrodes remain attached to the participant's head for the duration of the encoding phase.
Device: sham transcranial direct current stimulation
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.




Primary Outcome Measures :
  1. Memory performance [ Time Frame: directly after the encoding, expected to be up to 3 minutes ]
    Number of correct responses


Secondary Outcome Measures :
  1. Profile of Mood States (POMS; before stimulation) [ Time Frame: 3 minutes ]
    Changes in the subjective measure mood, assessed with questionnaire. Scores for each item is recorded as 0 for 'not at all' up to 6 for 'very strong'. A Total Mood Disturbance (TMD) score is calculated by summing the totals for the negative subscales dejection (14 items), fatigue (7 items) and discontent (7 items) and then subtracting the total for the positive subscale zest (7 items).

  2. Profile of Mood States (POMS; after stimulation) [ Time Frame: 3 minutes ]
    Changes in the subjective measure mood, assessed with questionnaire. Scores for each item is recorded as 0 for 'not at all' up to 6 for 'very strong'. A Total Mood Disturbance (TMD) score is calculated by summing the totals for the negative subscales dejection (14 items), fatigue (7 items) and discontent (7 items) and then subtracting the total for the positive subscale zest (7 items).

  3. Positive and Negative Affect Schedule (PANAS; before stimulation) [ Time Frame: 2 minutes ]
    Changes in the subjective measure mood, assessed with self-report questionnaire splitted up into two mood scales. One scale measures a person's positive emotion and the other scale measures the negative. Each segment has ten terms, which can be rated on a scale of 1 to 5 to indicate the extent to which the respondent agrees that this applies to him (higher values means higher agreement).

  4. Positive and Negative Affect Schedule (PANAS; after stimulation) [ Time Frame: 2 minutes ]
    Changes in the subjective measure mood, assessed with self-report questionnaire splitted up into two mood scales. One scale measures a person's positive emotion and the other scale measures the negative. Each segment has ten terms, which can be rated on a scale of 1 to 5 to indicate the extent to which the respondent agrees that this applies to him (higher values means higher agreement).



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent
  • Non-smokers
  • Right-handedness
  • Native German speakers or comparable level of fluency
  • Normal or corrected-to-normal vision

Exclusion Criteria:

  • Neurological or psychiatric condition (other than diagnosed cognitive impairment)
  • Past head injuries
  • Magnetizable implants
  • History of seizures
  • Current or life-time alcohol or drug abuse
  • Skin diseases
  • tES in the 3 months preceding or during the present study
  • Caffeine 3 hours prior to training

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): NCT03959462


Locations
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Switzerland
Klinik für Alterspsychiatrie und Psychotherapie UPD Bern
Bern, Switzerland, 3000
Sponsors and Collaborators
University of Bern
Novartis
Investigators
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Principal Investigator: Jessica Peter, Dr Universitäre psychiatrische Dienste Bern (UPD), University of Bern

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Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT03959462     History of Changes
Other Study ID Numbers: 2017-01664
17C195 ( Other Grant/Funding Number: Novartis Foundation for medical-biological research )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Bern:
tDCS