Temporal Interference and Depression
- Conditions
- Major Depressive Disorder
- Interventions
- Device: Sham stimulationDevice: Temporal Interference stimulation
- Registration Number
- NCT05295888
- Lead Sponsor
- Unity Health Toronto
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Arm Sham stimulation Sham stimulation (total 2700 sec): ramp-up (30-60 sec) =\> ramp-down (30-60 sec) =\> stimulation (130Hz, 0mA, 2520-2610 sec) =\> ramp-down (30-60 sec) Experimental Arm Temporal Interference stimulation 130Hz TI stimulation (total 2700 sec): ramp-up (30-60 sec) =\> stimulation (130Hz, 2mA per electrode pair, 4mA total, 2580-2640 sec) =\> ramp-down (30-60sec)
- Primary Outcome Measures
Name Time Method Neuroimaging - Perfusion metrics End of 2nd week of intervention Cerebral blood flow within SCC to demonstrate SCC target engagement to TI stimulation
Neuroimaging - Signal variance End of 2nd week of intervention Signal variance within SCC to demonstrate SCC target engagement to TI stimulation
Neuroimaging - Functional connectivity 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 End of 2nd week of intervention Anatomical connectivity of SCC to demonstrate SCC target engagement to TI stimulation
- Secondary Outcome Measures
Name Time Method Tolerability - Adverse events End of 1st week of intervention, end of 2nd week of intervention, 1 week post-intervention, and 4 weeks post-intervention Incidence of treatment-emergent adverse events
Trial Feasibility - Dropout rate End of 1st week of intervention, end of 2nd week of intervention, 1 week post-intervention, and 4 weeks post-intervention The proportion of participants who discontinue participation in the study before completion
Trial Feasibility - Recruitment rate Enrollment The number of participants enrolled into the study per month
Trial Feasibility - Intervention adherence End of 2nd week of intervention Percentage of participants who completed ≥80% of scheduled intervention sessions
Clinical change in depression symptoms Baseline, each intervention visit (5 times/week for 2 weeks), 1 week post-intervention, and 4 weeks post-intervention 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.
EEG Signals - Frequency domain features Baseline, end of 1st week of intervention, and end of 2nd week of intervention Changes in frequency domain features of gamma oscillation on resting-state EEG Changes in frequency domain features of theta oscillation on resting-state EEG
EEG Signals - Functional connectivity Baseline, end of 1st week of intervention, and end of 2nd week of intervention Changes in functional connectivity on resting-state EEG
Correlation between EEG and depression symptoms Baseline, end of 1st week of intervention, and end of 2nd week of intervention Correlation between changes in features of gamma or theta oscillations (EEG) and changes in depression symptoms measured by the HAM-D
EEG Signals - MMN event-related potential Baseline, end of 1st week of intervention, and end of 2nd week of intervention Changes in mismatch negativity (MMN) event-related potential amplitude and latency
EEG Signals - Time domain features Baseline, end of 1st week of intervention, and end of 2nd week of intervention Changes in time domain features of gamma oscillation on resting-state EEG Changes in time domain features of theta oscillation on resting-state EEG
Trial Locations
- Locations (1)
Interventional Psychiatry Program, St. Michael's Hospital - Unity Health Toronto
🇨🇦Toronto, Ontario, Canada