Actively Recruiting
Temporal Interference and Depression
Led by Unity Health Toronto · Updated on 2025-04-24
30
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
U
Unity Health Toronto
Lead Sponsor
B
Beth Israel Deaconess Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Temporal Interference and Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent before any study procedures
- Are outpatients
- Meet DSM-5 criteria for major depressive disorder with a current major depressive episode without psychotic features
- Male or female aged 18 to 65 years inclusive
- Have a Montgomery-5sberg Depression Rating Scale (MADRS) total score of 20 or higher at screening
- No increase or start of psychotropic medication in the 4 weeks before screening
- Able to follow the treatment schedule
- Pass the TI adult safety screening questionnaire
- Able to understand and comply with study requirements as judged by investigators
You will not qualify if you...
- Have an acute alcohol or substance use disorder or required detoxification within 3 months before screening
- Have major unstable medical illness, active hepatitis B/C, HIV, active COVID-19, pacemaker or implanted medication pump
- Have active suicidal intent as confirmed by clinical assessments
- Have a diagnosis of autism, dementia, or intellectual disability
- Take medications prohibited by the study protocol
- Are pregnant or lactating
- Have any current or prior diagnosis of bipolar disorder, psychotic depression, schizophrenia, or related psychotic disorders
- Have obsessive-compulsive disorder or post-traumatic stress disorder causing greater impairment than MDD
- Have a personality disorder causing greater impairment than MDD
- Have received prior TI treatment
- Have significant neurological disorders or history of severe head trauma
- Have intracranial implants or metal objects in or near the head that cannot be safely removed
- Are not in stable psychotherapy treatment for at least 3 months or expect changes in therapy during the study
- Have clinically significant lab abnormalities
- Take medications that may limit TI effectiveness
- Have significant sensory impairments preventing study participation
- Have unstable clinical findings affecting or affected by study medication
- Have untreated thyroid conditions or unstable thyroid treatment
- Have other conditions that may prevent study completion
- Have hairstyles or headdresses preventing electrode contact
- Have contraindications to TI or MRI such as large hip circumference or metal in the body
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Interventional Psychiatry Program, St. Michael's Hospital - Unity Health Toronto
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
Research Team
V
Venkat Bhat, MD MSc
CONTACT
I
Ilya Demchenko, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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