NCT06942559

Brain-Oscillation Synchronized Stimulation of the DMPFC

Brain-Oscillation Synchronized Stimulation of the DMPFC: A Single-Blind Study for Personalized Neuromodulation in OCD

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to obtain initial evidence about the clinical efficacy and modulation of neurophysiological markers in obsessive compulsive disorder (OCD) using personalized (i.e., electroencephalography (EEG)-triggered) repetitive transcranial magnetic stimulation (rTMS) as compared to non-personalized (i.e., non-EEG triggered), standard rTMS applied to the dorsomedial prefrontal cortex.

Detailed description

This trial uses a prospective, randomized, single-blind study design with two treatment arms at the Centre for Addiction and Mental Health (CAMH) in Toronto, ON. The study aims to compare the clinical effects of EEG-triggered, personalized rTMS (i.e., experimental arm) in the treatment of OCD to those of non-EEG triggered, non-personalized rTMS (i.e., active-comparator arm). Additionally, the study aims to compare the modulation of neurophysiological (i.e., EEG) markers of OCD between the two arms. Study treatment will be administered five days per week across a six-week treatment course for a total of 30 sessions. Both rTMS arms will use the same TMS coil, stimulation intensity, number of pulses, and anatomical target (i.e., dorsomedial prefrontal cortex). Clinical outcomes will be measured using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) with clinical response defined as a ≥30% improvement on the Y-BOCS. The self-reported revised Obsessive Compulsive Inventory (OCI-R) and Clinical Global Impressions - Improvement (CGI-I) scale will also be used. Neurophysiological outcomes will be measured by the change in frontoparietal theta amplitude (i.e., 4-7 Hz) and power of TMS-induced theta oscillations.

Conditions

• Obsessive Compulsive Disorder (OCD)
• Treatment Resistant Obsessive Compulsive Disorder

Interventions

Type	Name	Description
DEVICE	EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)	The rTMS intervention will be delivered using the MagPro XP - Orange Edition stimulator and COOL D-B80 coil to the dorsomedial prefrontal cortex 4 cm anterior to the foot hotspot. EEG data will be analyzed in real-time using the bossdevice MEDICAL and TMS pulses will be synchronized to the negative peak of the frontoparietal theta oscillation. 500 consecutive EEG theta-oscillation negative-peak triggered quadruplet bursts with a 5 ms inter-pulse interval will be applied at an average inter-burst interval of 2 s. The therapeutic intervention consists of 30 sessions of 2000 TMS pulses each for a total duration per treatment session of 17 minutes.
DEVICE	Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)	The rTMS intervention will be delivered using the MagPro XP - Orange Edition stimulator and COOL D-B80 coil to the dorsomedial prefrontal cortex 4 cm anterior to the foot hotspot. High-frequency rTMS consisting of 50 trains at 20 Hz (2 s on, 18 s off) will be delivered. The therapeutic intervention consists of 30 sessions of 2000 TMS pulses each for a total duration per treatment session of 17 minutes.

Timeline

• Start date: 2025-01-29
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2025-04-24
• Last updated: 2025-04-24

Locations

1 site across 1 country: Canada