RecruitingNot ApplicableNCT06942559

Brain-Oscillation Synchronized Stimulation of the DMPFC

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


Sponsor

Centre for Addiction and Mental Health

Enrollment

48 participants

Start Date

Jan 29, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing brain stimulation (using TMS — a non-invasive magnetic pulse device) that is synchronised to your brain waves to reduce OCD symptoms in people who have not responded adequately to standard therapy. **You may be eligible if...** - You are aged 18–65 - You have OCD as your primary diagnosis, confirmed by a psychiatric interview - Your OCD symptoms are severe (Y-BOCS score over 20) - You have tried at least one course of cognitive-behavioural therapy or an SSRI antidepressant and it did not work well enough - You are fluent in English and have not changed or started any psychiatric medication in the past 4 weeks **You may NOT be eligible if...** - You have a metal implant, pacemaker, or other TMS contraindication - You have a history of neurological conditions (e.g. epilepsy, stroke, Parkinson's disease, brain injury) - You are pregnant or breastfeeding - You have a substance use disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEEG-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.

DEVICENon-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.


Locations(1)

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

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NCT06942559


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