DepressionNCT05555056
Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation
A study testing MxN-9 HD-tES Stimulator (Soterix Inc.) in people with Depression and Anxiety, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of the proposed study is to examine if a repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Stress Disorders, Post-Traumatic
- What is being tested?
- MxN-9 HD-tES Stimulator (Soterix Inc.)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 1 Apr 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients who have agreed to participate in virtual mental health treatment at health care sites throughout Manitoba. Eligible participants will be those enrolled in a range of mental health programs, including CBT, DBT, virtual hospital wards, and group-based treatment (e.g., CBTm, Managing Difficult Emotions, etc). The target population will also include providers and decision makers offering virtual mental health programs. Individuals must meet the following criteria to be eligible to participate in the study: 1) must be a patient/client enrolled in a virtual mental health program OR a provider/decision maker offering a virtual mental health program, and 2) located within Manitoba
Who cannot join
- contraindication for MRI (e.g., metallic implants and claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the proposed study is to examine if a repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral therapy with mindfulness classes.
- Conditions
- Depression, Anxiety, Stress Disorders, Post-Traumatic
- Being tested
- MxN-9 HD-tES Stimulator (Soterix Inc.), Sham Stimulation
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MxN-9 HD-tES Stimulator (Soterix Inc.)Device
Patients will be stimulated with high definition transcranial direct current stimulation (HD-tDCS) for 5 weeks (every weekdays; one session per day). In each session, a constant current at 2mA will be passed on the target brain areas for 20 minutes.
Sham StimulationDevice
The same stimulation protocol will be used as in Active stimulation except that a sham mode will be selected in the stimulator machine.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Active comparator | MxN-9 HD-tES Stimulator (Soterix Inc.) will be used to deliver direct current (High-Definition Transcranial Direct Current Stimulation) to the target brain areas via electrodes and conducive gels. A constant current will be applied for 20 minutes with peak current of 2 mA. The 9 electrodes (8 channels + 1 ground) positions and current intensity have been determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left VLPFC (x=-50, y=+26, z=+8) and the PCC (x=1, y=-61, z=38) with inward field orientation. Receives: Device: MxN-9 HD-tES Stimulator (Soterix Inc.) |
| Inactive Stimulation | Sham comparator | The current will be applied for 30 seconds ramp-up followed by 30 seconds ramp-down, and thus no active stimulation will be administered except for the initial and last 1 minutes of 20 minute stimulation duration. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Connectivity
Functional Connectivity between the targeted brain regions measured by resting state fMRI (level of synchronous fMRI signal, standardized)
Measured: Change from Baseline Functional Connectivity after 5 month HD-tDCS/CBTm treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Sep 2023
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Thirty participants among those who are enrolled in the parent clinical trial will be recruited. Participants will receive 5-week CBTm treatment and a battery of psychological assessment as part of the parent clinical trial. Individuals enrolled in the current study will receive daily HD-tDCS during the period of CBTm treatment (5-week). Half of the individuals will receive real stimulation and the other half will receive sham stimulation. Participants will be scanned with MRI before and after the 5-week treatment. EEG data will be collected before (10 minutes), during (20 minutes) and after (20 minutes) each HD-tDCS session .
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Winnipeg Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555056
- Sponsor's protocol ID
- HS25578
- Status last verified
- Apr 2026
- First submitted
- 20 Sep 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation
- ClinicalTrials.gov ID
- NCT05555056
- Acronym / sponsor ID
- HS25578
- Conditions
- Depression, Anxiety, Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Winnipeg Foundation
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 26 Sep 2022 (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.
The purpose of the proposed study is to examine if a repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral therapy with mindfulness classes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Thirty participants among those who are enrolled in the parent clinical trial will be recruited. Participants will receive 5-week CBTm treatment and a battery of psychological assessment as part of the parent clinical trial. Individuals enrolled in the current study will receive daily HD-tDCS during the period of CBTm treatment (5-week). Half of the individuals will receive real stimulation and the other half will receive sham stimulation. Participants will be scanned with MRI before and after the 5-week treatment. EEG data will be collected before (10 minutes), during (20 minutes) and after (20 minutes) each HD-tDCS session .
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Active comparator | Device: MxN-9 HD-tES Stimulator (Soterix Inc.)MxN-9 HD-tES Stimulator (Soterix Inc.) will be used to deliver direct current (High-Definition Transcranial Direct Current Stimulation) to the target brain areas via electrodes and conducive gels. A constant current will be applied for 20 minutes with peak current of 2 mA. The 9 electrodes (8 channels + 1 ground) positions and current intensity have been determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left VLPFC (x=-50, y=+26, z=+8) and the PCC (x=1, y=-61, z=38) with inward field orientation. |
| Inactive Stimulation | Sham comparator | Device: Sham StimulationThe current will be applied for 30 seconds ramp-up followed by 30 seconds ramp-down, and thus no active stimulation will be administered except for the initial and last 1 minutes of 20 minute stimulation duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients who have agreed to participate in virtual mental health treatment at health care sites throughout Manitoba. Eligible participants will be those enrolled in a range of mental health programs, including CBT, DBT, virtual hospital wards, and group-based treatment (e.g., CBTm, Managing Difficult Emotions, etc). The target population will also include providers and decision makers offering virtual mental health programs. Individuals must meet the following criteria to be eligible to participate in the study: 1) must be a patient/client enrolled in a virtual mental health program OR a provider/decision maker offering a virtual mental health program, and 2) located within Manitoba
Key exclusion criteria (1 listed)
- contraindication for MRI (e.g., metallic implants and claustrophobia)
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 |
|---|---|---|
| MxN-9 HD-tES Stimulator (Soterix Inc.)Patients will be stimulated with high definition transcranial direct current stimulation (HD-tDCS) for 5 weeks (every weekdays; one session per day). In each session, a constant current at 2mA will be passed on the target brain areas for 20 minutes. | Device | Active Stimulation |
| Sham StimulationThe same stimulation protocol will be used as in Active stimulation except that a sham mode will be selected in the stimulator machine. | Device | Inactive Stimulation |
Primary outcome
Functional Connectivity
Time frame: Change from Baseline Functional Connectivity after 5 month HD-tDCS/CBTm treatment
Functional Connectivity between the targeted brain regions measured by resting state fMRI (level of synchronous fMRI signal, standardized)
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 1 May 2026.
Related trials for Depression
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
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 MxN-9 HD-tES Stimulator (Soterix Inc.) in people with Depression and Anxiety, 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 1 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 1 May 2026. 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?
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?
Functional Connectivity (time frame: Change from Baseline Functional Connectivity after 5 month HD-tDCS/CBTm treatment). 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 1 May 2026.