Evaluation of Temporal Interference in Target Engagement of Subgenual Cingulate Cortex in the Treatment of Major Depressive Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

• 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)

Locations
Other Locations
Canada
Interventional Psychiatry Program, St. Michael's Hospital - Unity Health Toronto
RECRUITING
Toronto
Contact Information
Primary
Venkat Bhat, MD MSc
Venkat.Bhat@unityhealth.to
416-360-4000
Backup
Ilya Demchenko, MSc
Ilya.Demchenko@unityhealth.to
416-360-4000
Time Frame
Start Date: 2025-05-15
Estimated Completion Date: 2027-12
Participants
Target number of participants: 30
Treatments
Experimental: Experimental Arm
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)
Sham_comparator: Sham Arm
Sham stimulation (total 30 min) + mood induction paradigm: ramp-up (30 sec) =\> ramp-down (30 sec) =\> stimulation (130Hz, 0mA, 29 min)
Related Therapeutic Areas
Sponsors
Leads: Unity Health Toronto
Collaborators: Centre for Addiction and Mental Health, Charite University, Berlin, Germany, Toronto Metropolitan University, Beth Israel Deaconess Medical Center, Northeastern University

This content was sourced from clinicaltrials.gov