HealthyNormal_tDCSNCT03027869
Normal Brain Imaging Database for Brain Disorder Studies
A study testing transcranial direct current stimulation in people with Healthy, run by University of Manitoba at 1 site in Canada.
Trial summary
Healthy volunteers will be recruited. All subjects will be tested a battery of neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET) and magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jun 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- N/A
Who cannot join
- History of any neurological or psychiatric diseases;
- Abnormal MRI;
- metal implants or a cardiac pacemaker;
- Pregnant or breastfeeding women (female subjects of child bearing potential will be screened for pregnancy before MRI imaging).
- severe hypertension.
- cardiovascular disease.
- Family history of epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Healthy volunteers will be recruited. All subjects will be tested a battery of neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET) and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with transcranial direct current stimulation (tDCS) for 15 minutes. A third of subjects will receive real tDCS on the left prefrontal cortex, a third on the right prefrontal cortex, and the other third will receive sham tDCS.
- Conditions
- Healthy
- Being tested
- transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
15 minute anodal stimulation 1.5mA
| Study group | Role | What they receive |
|---|---|---|
| Real Left DLPFC tDCS | Active comparator | Real tDCS on the left dorsolateral prefrontal cortex Receives: Device: transcranial direct current stimulation |
| Sham tDCS | Sham comparator | 30sec ramp-up and 30sec ramp-down Receives: Device: transcranial direct current stimulation |
| Real Right DLPFC tDCS | Active comparator | Real tDCS on the right dorsolateral prefrontal cortex Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional connectivity
The functional connectivity of the right caudate nucleus will be estimated using graph theory analysis technique of resting-state fMRI.
Measured: immediate (less than 30 minutes)
Secondary outcomes (1)
Stroop task performance
the executive function that is thought to involve the caudate nucleus will be examined
Measured: immediate (less than 60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start28 Jun 2017
- Primary completion11 Mar 2020
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hyun Ko, PhD, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027869
- Sponsor's protocol ID
- B2016:074
- Acronym
- Normal_tDCS
- Status last verified
- Mar 2025
- First submitted
- 16 Jan 2017
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Carther-Krone T, McAllister ZA, Choi EH, Ryner L, Ko JH. Asymmetric Modulation of Brain Connectivity by Anodal Transcranial Direct Current Stimulation in Healthy Individuals: A Single-Blind, Randomized Sham-Controlled Trial. Hum Brain Mapp. 2025 May;46(7):e70218. doi: 10.1002/hbm.70218.
PubMed 40312821
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Brain Imaging Database for Brain Disorder Studies
- ClinicalTrials.gov ID
- NCT03027869
- Acronym / sponsor ID
- Normal_tDCS / B2016:074
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jan 2017 (estimated)
- 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.
Healthy volunteers will be recruited. All subjects will be tested a battery of neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET) and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with transcranial direct current stimulation (tDCS) for 15 minutes. A third of subjects will receive real tDCS on the left prefrontal cortex, a third on the right prefrontal cortex, and the other third will receive sham tDCS.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real Left DLPFC tDCS | Active comparator | Device: transcranial direct current stimulationReal tDCS on the left dorsolateral prefrontal cortex |
| Sham tDCS | Sham comparator | Device: transcranial direct current stimulation30sec ramp-up and 30sec ramp-down |
| Real Right DLPFC tDCS | Active comparator | Device: transcranial direct current stimulationReal tDCS on the right dorsolateral prefrontal cortex |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- N/A
Key exclusion criteria (7 listed)
- History of any neurological or psychiatric diseases;
- Abnormal MRI;
- metal implants or a cardiac pacemaker;
- Pregnant or breastfeeding women (female subjects of child bearing potential will be screened for pregnancy before MRI imaging).
- severe hypertension.
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 |
|---|---|---|
| transcranial direct current stimulation15 minute anodal stimulation 1.5mA | Device | Real Left DLPFC tDCS, Real Right DLPFC tDCS, Sham tDCS |
Primary outcome
functional connectivity
Time frame: immediate (less than 30 minutes)
The functional connectivity of the right caudate nucleus will be estimated using graph theory analysis technique of resting-state fMRI.
1 secondary outcome
Stroop task performance
Time frame: immediate (less than 60 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 40312821Carther-Krone T, McAllister ZA, Choi EH, Ryner L, Ko JH. Asymmetric Modulation of Brain Connectivity by Anodal Transcranial Direct Current Stimulation in Healthy Individuals: A Single-Blind, Randomized Sham-Controlled Trial. Hum Brain Mapp. 2025 May;46(7):e70218. doi: 10.1002/hbm.70218.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Healthy, run by University of Manitoba at 1 site in Canada.
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 1 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
functional connectivity (time frame: immediate (less than 30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03027869, which also lists 1 linked publication.
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 3 Apr 2025.