Real tDCSNCT03959462
Supporting Decisions With Transcranial Direct Current Stimulation in Healthy Young and Elderly Individuals
A study testing real anodal transcranial direct current stimulation in people with Real tDCS and Sham tDCS, run by University of Bern at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- What is being tested?
- real anodal transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Mar 2018to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Non-smokers
- Right-handedness
- Native German speakers or comparable level of fluency
- Normal or corrected-to-normal vision
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Alterspsychiatrie und Psychotherapie UPD Bern
Bern, 3000
About this study
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.
- Being tested
- real anodal transcranial direct current stimulation, sham transcranial direct current stimulation
- Keywords
- tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real anodal transcranial direct current stimulationDevice
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.
sham transcranial direct current stimulationDevice
A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of Stimulation on the Decisions
Number of words which were rated as positive or negative.
Measured: 10 minutes
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start6 Mar 2018
- Primary completion30 Aug 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Real tDCSStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated to one of 2 groups: real tDCS or sham.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Jessica Peter, PD, Principal investigator, Universitäre psychiatrische Dienste Bern (UPD), University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959462
- Sponsor's protocol ID
- 2017-01664
- Other IDs
- 17C195, 2017
- Status last verified
- May 2023
- First submitted
- 20 May 2019
- Last updated
- 10 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Decisions With Transcranial Direct Current Stimulation in Healthy Young and Elderly Individuals
- ClinicalTrials.gov ID
- NCT03959462
- Acronym / sponsor ID
- 2017-01664
- Keywords
- tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are allocated to one of 2 groups: real tDCS or sham.
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Device: real anodal transcranial direct current stimulation20 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. |
| Sham tDCS | Sham comparator | Device: sham transcranial direct current stimulation30 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. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent
- Non-smokers
- Right-handedness
- Native German speakers or comparable level of fluency
- Normal or corrected-to-normal vision
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real anodal transcranial direct current stimulationA neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used. | Device | Real tDCS |
| sham transcranial direct current stimulationA neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used. | Device | Sham tDCS |
Primary outcome
Influence of Stimulation on the Decisions
Time frame: 10 minutes
Number of words which were rated as positive or negative.
4 secondary outcomes
Profile of Mood States (POMS; before stimulation)
Time frame: 3 minutes
Profile of Mood States (POMS; after stimulation)
Time frame: 3 minutes
Positive and Negative Affect Schedule (PANAS; before stimulation)
Time frame: 2 minutes
Positive and Negative Affect Schedule (PANAS; after stimulation)
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Peter, PD principal investigator
Universitäre psychiatrische Dienste Bern (UPD), University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real anodal transcranial direct current stimulation in people with Real tDCS and Sham tDCS, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influence of Stimulation on the Decisions (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.