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

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.

Study Overview

• Status: Completed
• Conditions: Sham tDCS; Real tDCS
• Intervention / Treatment: Device: real anodal transcranial direct current stimulation; Device: sham transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3000
    • Klinik für Alterspsychiatrie und Psychotherapie UPD Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 decision task.	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 decision task.	Device: sham transcranial direct current stimulation; A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Influence of Stimulation on the Decisions	Number of words which were rated as positive or negative.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profile of Mood States (POMS; before stimulation)	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 minutes
Profile of Mood States (POMS; after stimulation)	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 minutes
Positive and Negative Affect Schedule (PANAS; before stimulation)	Changes in the subjective measure mood, assessed with self-report questionnaire divided 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).	2 minutes
Positive and Negative Affect Schedule (PANAS; after stimulation)	Changes in the subjective measure mood, assessed with self-report questionnaire divided 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).	2 minutes

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: Novartis
• Investigators: Principal Investigator: Jessica Peter, PD, Universitäre psychiatrische Dienste Bern (UPD), University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: tDCS
• Other Study ID Numbers: 2017-01664; 17C195 (Other Grant/Funding Number: Novartis Foundation for medical-biological research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No