NCT03959462

Brief Summary

Decisions are part of the daily life. On the neuronal level, activity in the dorsolateral prefrontal cortex (dlPFC) is important during complex decisions (e.g., whether something is emotional for a person or not). We apply transcranial direct current stimulation (tDCS) with the aim to increase dlPFC activity and thereby modulate decisions towards emotional content.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

4.5 years

First QC Date

May 20, 2019

Last Update Submit

May 9, 2023

Conditions

Real tDCSSham tDCS

Keywords

tDCS

Outcome Measures

Primary Outcomes (1)

  • Influence of Stimulation on the Decisions

    Number of words which were rated as positive or negative.

    10 minutes

Secondary Outcomes (4)

  • Profile of Mood States (POMS; before stimulation)

    3 minutes

  • Profile of Mood States (POMS; after stimulation)

    3 minutes

  • Positive and Negative Affect Schedule (PANAS; before stimulation)

    2 minutes

  • Positive and Negative Affect Schedule (PANAS; after stimulation)

    2 minutes

Study Arms (2)

Real tDCS

EXPERIMENTAL

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 decision task.

Device: real anodal transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

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 decision task.

Device: sham transcranial direct current stimulation

Interventions

real anodal transcranial direct current stimulationDEVICE

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.

Real tDCS
sham transcranial direct current stimulationDEVICE

A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.

Sham tDCS

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Alterspsychiatrie und Psychotherapie UPD Bern

Bern, 3000, Switzerland

Location

Study Officials

  • Jessica Peter, PD

    Universitäre psychiatrische Dienste Bern (UPD), University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind design
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants are allocated to one of 2 groups: real tDCS or sham.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 22, 2019

Study Start

March 6, 2018

Primary Completion

August 30, 2022

Study Completion

December 30, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)