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

Sham tDCS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03959462
• Other study ID #: 2017-01664
• Secondary ID: 17C195
• Status: Completed
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: December 30, 2022

Study information

• Verified date: May 2023
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: December 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Real tDCS
• Sham tDCS

Intervention

Device:
• real anodal transcranial direct current stimulation
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.
• sham transcranial direct current stimulation
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.

Locations

Country	Name	City	State
Switzerland	Klinik für Alterspsychiatrie und Psychotherapie UPD Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	Novartis

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influence of Stimulation on the Decisions	Number of words which were rated as positive or negative.	10 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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