Major Depressive DisorderTINCT05295888
Temporal Interference and Depression
A study testing Temporal Interference stimulation in people with Major Depressive Disorder, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Major Depressive Disorder (MDD) has a high prevalence, is the leading cause of disability, and currently available interventions are associated with side effects and high treatment resistance. There is an urgent need for the development of novel interventions for MDD with alternate mechanisms of action. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Temporal Interference stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2025to Dec 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- provide written informed consent before initiation of any study-related procedures
- are outpatients
- meet the DSM-5 criteria for major depressive disorder (MDD) with a current major depressive episode (MDE) without psychotic features as confirmed at Screening by the Mini International Neuropsychiatric Interview (MINI)
- are male or female, 18 to 65 years of age (inclusive) at screening
- have a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 20 (moderate to severe depression) at screening
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
Show all 9Show fewer
- able to adhere to the treatment schedule
- pass the TI adult safety screening questionnaire
- are able to understand and comply with the requirements of the study, as judged by the investigator(s)
Who cannot join
- have an acute alcohol or substance use disorder, withdrawal symptoms requiring detoxification, or went through detoxification treatment (inpatient or outpatient) within 3 months before Screening, as obtained from MINI, Module I (Alcohol Use Disorder) and Module J (Substance Use Disorder, Non-Alcohol) assessed at Screening
- have a concomitant major unstable medical illness, active hepatitis B virus (HBV), hepatitis C virus (HPC), human immunodeficiency virus (HIV), active COVID-19 infection, cardiac pacemaker or implanted medication pump, as per medical history provided by the participant
- have active suicidal intent, confirmed by a 'Yes' response to Question B3 AND either Question B10 or B11, obtained from the MINI Suicidality, Module B (Suicidality), OR confirmed by the MADRS item #10 score ≥ 4, both assessed at Screening
- have a current clinical diagnosis of autism, dementia, or intellectual disability
- take medications prohibited by the protocol. Medications will be reviewed by the responsible MD
- are pregnant or lactating
Show all 21Show fewer
- have any prior or current diagnosis of bipolar I or II disorder, MDD with psychotic features, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms as obtained from MINI, Module C (Manic and Hypomanic Episodes) and Module K (Psychotic Disorders and Mood Disorders with Psychotic Features) assessed at Screening
- have any prior or current diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), confirmed by MINI and assessed by a study investigator to be primary and causing greater impairment than MDD
- have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
- have received TI for any previous indication due to the potential compromise of subject blinding
- have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space-occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than 5 minutes, current history of poorly controlled migraines including chronic medication for migraine prevention
- have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- if participating in psychotherapy, have NOT been in stable treatment for at least 3 months prior to entry into the study or anticipate change in the frequency of therapeutic sessions or therapeutic focus over the duration of the study
- have a clinically significant laboratory abnormality, in the opinion of one of the principal investigators or study physicians
- currently take medications that potentially limit the TI efficacy
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with an interview)
- have a clinical finding that is unstable or that, in the opinion of the investigator(s), would be negatively affected by the study medication or that would affect the study medication (e.g., diabetes mellitus, hypertension, unstable angina)
- have uncorrected hypothyroidism or hyperthyroidism. Subjects needing a thyroid hormone supplement to treat hypothyroidism will be excluded if they have NOT been on a stable dose of the medication for 30 days prior to enrolment
- have any other condition that, in the opinion of the investigator(s), would adversely affect the subject's ability to complete the study or its measure
- wear a hairstyle or headdress at the time of the stimulation that prevents electrode contact with the scalp or would interfere with the stimulation (e.g., thick or curly hair)
- have any contraindications for receiving TI or undergoing MRI scans (e.g., hip circumference >180 cm or metal in the body)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Interventional Psychiatry Program, St. Michael's Hospital - Unity Health Toronto
Toronto, Ontario, M5B 1W8
Venkat Bhat, MD MSc, 416-864-2755
Venkat Bhat, MD MSc
About this study
Official title: Evaluation of Temporal Interference in Target Engagement of Subgenual Cingulate Cortex in the Treatment of Major Depressive Disorder
Major Depressive Disorder (MDD) has a high prevalence, is the leading cause of disability, and currently available interventions are associated with side effects and high treatment resistance. There is an urgent need for the development of novel interventions for MDD with alternate mechanisms of action. Temporal Interference (TI) stimulation is a newly emerging form of transcranial alternating current stimulation (tACS) that involves the application of two high-frequency currents at slightly different kHz frequencies. Since neurons, due to their intrinsic low-pass filtering, do not respond to high frequencies (i.e. > 100 Hz), TI relies on the 'beat' interaction leading to neuromodulation at any given location, resulting in a much smaller focus and allowing for better targeting. The subgenual cingulate cortex (SCC) appears to be critical in the pathophysiology of depression and treatment response, especially in treatment-resistant cases. Non-invasive treatments, however, are not able to accurately target SCC due to its deep location within the brain. In this trial, 30 participants meeting the diagnostic criteria for MDD will be randomized to receive 10 sessions of 130 Hz TI delivered daily for 30 minutes, or 10 sessions of sham stimulation. During the stimulation, participants will be watching emotional film clips to enhance target engagement. The investigators will collect metrics of SCC target engagement using the resting-state fMRI and EEG technologies, and determine feasibility, tolerability, safety, and therapeutic efficacy of TI stimulation in MDD. The results of this trial will inform the TI technology as a therapeutic tool for network-based psychiatric disorders, including MDD, and be vital for the design and development of a large-scale randomized-controlled trial.
- Conditions
- Major Depressive Disorder
- Being tested
- Temporal Interference stimulation, Sham stimulation
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporal Interference stimulationDevice
TI involves simultaneous delivery of independent currents to the brain at slightly different kHz frequencies, which are individually too high to recruit neural firing. However, the difference ('beat') frequency where the currents overlap (i.e., temporally interfered) is low enough to drive neural activity. The interferometrically derived low frequencies have been demonstrated to activate neurons at a selected focus without activation of surrounding regions in awake mice. The safety of the TI paradigm has been demonstrated in over 60 healthy human volunteers, and finite element modeling of simulations of TI fields in human anatomical models suggests that large subcortical structures such as the hippocampus or SCC could be selectively targeted. However, the precise TI parameters for selective engagement of SCC in healthy participants and in MDD is currently unknown.
Sham stimulationDevice
Electrodes will be placed in the same location on the head as that for the TI intervention; 0 mA of electrical current will be delivered to the brain (compared to 2 mA in the active intervention arm), therefore it is expected to elicit no changes in neural activity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | 130Hz TI stimulation (total 30 min) + mood induction paradigm: ramp-up (30 sec) => stimulation (130Hz, 2mA per electrode pair, 4mA total, 29 min) => ramp-down (30 sec) Receives: Device: Temporal Interference stimulation |
| Sham Arm | Sham comparator | Sham stimulation (total 30 min) + mood induction paradigm: ramp-up (30 sec) => ramp-down (30 sec) => stimulation (130Hz, 0mA, 29 min) Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroimaging - Signal variance
Signal variance within SCC to demonstrate SCC target engagement to TI stimulation
Measured: End of 2nd week of intervention
Neuroimaging - Functional connectivity
Seed-based resting-state functional connectivity of SCC to demonstrate SCC target engagement to TI stimulation
Measured: End of 2nd week of intervention
Neuroimaging - Anatomical connectivity
Anatomical connectivity of SCC to demonstrate SCC target engagement to TI stimulation
Measured: End of 2nd week of intervention
Neuroimaging - Perfusion metrics
Cerebral blood flow within SCC to demonstrate SCC target engagement to TI stimulation
Measured: End of 2nd week of intervention
Secondary outcomes (11)
Clinical change in depression symptoms
Change in symptoms of depression measured by the 17-item Hamilton Depression Rating Scale (HAM-D); scores range from 0 to 53, and higher scores indicate more severe depression symptoms.
Measured: Baseline, end of 1st week of intervention, end of 2nd week of intervention, 1 week post-intervention, and 4 weeks post-intervention
Clinical change in depression symptoms
Change in symptoms of depression measured by the 16-item Quick Inventory of Depressive Symptomatology; scores range from 0 to 48, and higher scores indicate more severe depression symptoms.
Measured: Baseline, each intervention visit (5 times/week for 2 weeks), 1 week post-intervention, and 4 weeks post-intervention
EEG Signals - Time domain features
Changes in time domain features of gamma oscillation on resting-state EEG Changes in time domain features of theta oscillation on resting-state EEG
Measured: Baseline, end of 1st week of intervention, and end of 2nd week of intervention
EEG Signals - Frequency domain features
Changes in frequency domain features of gamma oscillation on resting-state EEG Changes in frequency domain features of theta oscillation on resting-state EEG
Measured: Baseline, end of 1st week of intervention, and end of 2nd week of intervention
EEG Signals - Functional connectivity
Changes in functional connectivity on resting-state EEG
Measured: Baseline, end of 1st week of intervention, and end of 2nd week of intervention
Correlation between EEG and depression symptoms
Correlation between changes in features of gamma or theta oscillations (EEG) and changes in depression symptoms measured by the HAM-D
Measured: Baseline, end of 1st week of intervention, and end of 2nd week of intervention
EEG Signals - MMN event-related potential
Changes in mismatch negativity (MMN) event-related potential amplitude and latency
Measured: Baseline, end of 1st week of intervention, and end of 2nd week of intervention
Tolerability - Adverse events
Incidence of treatment-emergent adverse events
Measured: End of 1st week of intervention, end of 2nd week of intervention, 1 week post-intervention, and 4 weeks post-intervention
Trial Feasibility - Dropout rate
The proportion of participants who discontinue participation in the study before completion
Measured: End of 1st week of intervention, end of 2nd week of intervention, 1 week post-intervention, and 4 weeks post-intervention
Trial Feasibility - Recruitment rate
The number of participants enrolled into the study per month
Measured: Enrollment
Trial Feasibility - Intervention adherence
Percentage of participants who completed ≥80% of scheduled intervention sessions
Measured: End of 2nd week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start15 May 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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 Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- This is a pilot, sham-controlled, quadruple-blind clinical trial to demonstrate target engagement of SCC with TI, as well as assess feasibility, safety, tolerability, and preliminary therapeutic efficacy of TI stimulation in patients with MDD.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Northeastern University, Centre for Addiction and Mental Health, Charite University, Berlin, Germany, Toronto Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Venkat Bhat, MD MSc, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295888
- Sponsor's protocol ID
- 21-152
- Acronym
- TI
- Status last verified
- Apr 2025
- First submitted
- 8 Oct 2021
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demchenko I, Rampersad S, Datta A, Horn A, Churchill NW, Kennedy SH, Krishnan S, Rueda A, Schweizer TA, Griffiths JD, Boyden ES, Santarnecchi E, Bhat V. Target engagement of the subgenual anterior cingulate cortex with transcranial temporal interference stimulation in major depressive disorder: a protocol for a randomized sham-controlled trial. Front Neurosci. 2024 Aug 29;18:1390250. doi: 10.3389/fnins.2024.1390250. eCollection 2024.
PubMed 39268031
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Temporal Interference in Target Engagement of Subgenual Cingulate Cortex in the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05295888
- Acronym / sponsor ID
- TI / 21-152
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Northeastern University, Centre for Addiction and Mental Health, Charite University, Berlin, Germany, Toronto Metropolitan University
- Study start
- 15 May 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Mar 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.
Major Depressive Disorder (MDD) has a high prevalence, is the leading cause of disability, and currently available interventions are associated with side effects and high treatment resistance. There is an urgent need for the development of novel interventions for MDD with alternate mechanisms of action. Temporal Interference (TI) stimulation is a newly emerging form of transcranial alternating current stimulation (tACS) that involves the application of two high-frequency currents at slightly different kHz frequencies. Since neurons, due to their intrinsic low-pass filtering, do not respond to high frequencies (i.e. > 100 Hz), TI relies on the 'beat' interaction leading to neuromodulation at any given location, resulting in a much smaller focus and allowing for better targeting. The subgenual cingulate cortex (SCC) appears to be critical in the pathophysiology of depression and treatment response, especially in treatment-resistant cases. Non-invasive treatments, however, are not able to accurately target SCC due to its deep location within the brain. In this trial, 30 participants meeting the diagnostic criteria for MDD will be randomized to receive 10 sessions of 130 Hz TI delivered daily for 30 minutes, or 10 sessions of sham stimulation. During the stimulation, participants will be watching emotional film clips to enhance target engagement. The investigators will collect metrics of SCC target engagement using the resting-state fMRI and EEG technologies, and determine feasibility, tolerability, safety, and therapeutic efficacy of TI stimulation in MDD. The results of this trial will inform the TI technology as a therapeutic tool for network-based psychiatric disorders, including MDD, and be vital for the design and development of a large-scale randomized-controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a pilot, sham-controlled, quadruple-blind clinical trial to demonstrate target engagement of SCC with TI, as well as assess feasibility, safety, tolerability, and preliminary therapeutic efficacy of TI stimulation in patients with MDD.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: Temporal Interference stimulation130Hz TI stimulation (total 30 min) + mood induction paradigm: ramp-up (30 sec) => stimulation (130Hz, 2mA per electrode pair, 4mA total, 29 min) => ramp-down (30 sec) |
| Sham Arm | Sham comparator | Device: Sham stimulationSham stimulation (total 30 min) + mood induction paradigm: ramp-up (30 sec) => ramp-down (30 sec) => stimulation (130Hz, 0mA, 29 min) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- provide written informed consent before initiation of any study-related procedures
- are outpatients
- meet the DSM-5 criteria for major depressive disorder (MDD) with a current major depressive episode (MDE) without psychotic features as confirmed at Screening by the Mini International Neuropsychiatric Interview (MINI)
- are male or female, 18 to 65 years of age (inclusive) at screening
- have a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 20 (moderate to severe depression) at screening
Key exclusion criteria (21 listed)
- have an acute alcohol or substance use disorder, withdrawal symptoms requiring detoxification, or went through detoxification treatment (inpatient or outpatient) within 3 months before Screening, as obtained from MINI, Module I (Alcohol Use Disorder) and Module J (Substance Use Disorder, Non-Alcohol) assessed at Screening
- have a concomitant major unstable medical illness, active hepatitis B virus (HBV), hepatitis C virus (HPC), human immunodeficiency virus (HIV), active COVID-19 infection, cardiac pacemaker or implanted medication pump, as per medical history provided by the participant
- have active suicidal intent, confirmed by a 'Yes' response to Question B3 AND either Question B10 or B11, obtained from the MINI Suicidality, Module B (Suicidality), OR confirmed by the MADRS item #10 score ≥ 4, both assessed at Screening
- have a current clinical diagnosis of autism, dementia, or intellectual disability
- take medications prohibited by the protocol. Medications will be reviewed by the responsible MD
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 |
|---|---|---|
| Temporal Interference stimulationTI involves simultaneous delivery of independent currents to the brain at slightly different kHz frequencies, which are individually too high to recruit neural firing. However, the difference ('beat') frequency where the currents overlap (i.e., temporally interfered) is low enough to drive neural activity. The interferometrically derived low frequencies have been demonstrated to activate neurons at a selected focus without activation of surrounding regions in awake mice. The safety of the TI paradigm has been demonstrated in over 60 healthy human volunteers, and finite element modeling of simulations of TI fields in human anatomical models suggests that large subcortical structures such as the hippocampus or SCC could be selectively targeted. However, the precise TI parameters for selective engagement of SCC in healthy participants and in MDD is currently unknown. | Device | Experimental Arm |
| Sham stimulationElectrodes will be placed in the same location on the head as that for the TI intervention; 0 mA of electrical current will be delivered to the brain (compared to 2 mA in the active intervention arm), therefore it is expected to elicit no changes in neural activity. | Device | Sham Arm |
Primary outcome
Neuroimaging - Signal variance
Time frame: End of 2nd week of intervention
Signal variance within SCC to demonstrate SCC target engagement to TI stimulation
Neuroimaging - Functional connectivity
Time frame: End of 2nd week of intervention
Seed-based resting-state functional connectivity of SCC to demonstrate SCC target engagement to TI stimulation
Neuroimaging - Anatomical connectivity
Time frame: End of 2nd week of intervention
Anatomical connectivity of SCC to demonstrate SCC target engagement to TI stimulation
Neuroimaging - Perfusion metrics
Time frame: End of 2nd week of intervention
Cerebral blood flow within SCC to demonstrate SCC target engagement to TI stimulation
11 secondary outcomes
Clinical change in depression symptoms
Time frame: Baseline, end of 1st week of intervention, end of 2nd week of intervention, 1 week post-intervention, and 4 weeks post-intervention
Clinical change in depression symptoms
Time frame: Baseline, each intervention visit (5 times/week for 2 weeks), 1 week post-intervention, and 4 weeks post-intervention
EEG Signals - Time domain features
Time frame: Baseline, end of 1st week of intervention, and end of 2nd week of intervention
EEG Signals - Frequency domain features
Time frame: Baseline, end of 1st week of intervention, and end of 2nd week of intervention
EEG Signals - Functional connectivity
Time frame: Baseline, end of 1st week of intervention, and end of 2nd week of intervention
Correlation between EEG and depression symptoms
Time frame: Baseline, end of 1st week of intervention, and end of 2nd week of intervention
EEG Signals - MMN event-related potential
Time frame: Baseline, end of 1st week of intervention, and end of 2nd week of intervention
Tolerability - Adverse events
Time frame: End of 1st week of intervention, end of 2nd week of intervention, 1 week post-intervention, and 4 weeks post-intervention
Trial Feasibility - Dropout rate
Time frame: End of 1st week of intervention, end of 2nd week of intervention, 1 week post-intervention, and 4 weeks post-intervention
Trial Feasibility - Recruitment rate
Time frame: Enrollment
Trial Feasibility - Intervention adherence
Time frame: End of 2nd week of intervention
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 24 Apr 2025.
- Background: PubMed 39268031Demchenko I, Rampersad S, Datta A, Horn A, Churchill NW, Kennedy SH, Krishnan S, Rueda A, Schweizer TA, Griffiths JD, Boyden ES, Santarnecchi E, Bhat V. Target engagement of the subgenual anterior cingulate cortex with transcranial temporal interference stimulation in major depressive disorder: a protocol for a randomized sham-controlled trial. Front Neurosci. 2024 Aug 29;18:1390250. doi: 10.3389/fnins.2024.1390250. eCollection 2024.
- 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.
Venkat Bhat, MD MSc principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporal Interference stimulation in people with Major Depressive Disorder, run by Unity Health Toronto 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 9 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 24 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?
Contact Venkat Bhat, MD MSc (416-360-4000 ext. 76404, Venkat.Bhat@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroimaging - Signal variance (time frame: End of 2nd week of intervention). The study lists 4 primary outcomes in all. 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 NCT05295888, 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 24 Apr 2025.