Recruiting

Brain-Oscillation Stimulation

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06942559

Conditions

Obsessive Compulsive Disorder (OCD)

Treatment Resistant Obsessive Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)

Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Details

Brief 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.

Conditions

Obsessive Compulsive Disorder (OCD)

Treatment Resistant Obsessive Compulsive Disorder

Study ID

NCT06942559

Start date

Jan 29, 2025

Status verified date

Apr, 2025

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Are 18-65 years old;
2. Have OCD as a primary disorder, confirmed by a Mini-International Neuropsychiatric Interview (MINI) diagnosis of OCD, with treatment resistance defined as a failure of at least one course of cognitive-behavioural therapy or a single trial of an SSRI;
3. Does not meet criteria for substance use disorder as determined by the MINI (with the exception of nicotine and caffeine);
4. Have a Y-BOCS score >20;
5. Are fluent in the English language (spoken, written, reading);
6. Have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
7. Must be deemed to have capacity to provide informed consent;
8. Must sign and date the informed consent form;
9. Stated willingness to comply with all study procedures.

Exclusion Criteria:

1. Have any contraindications to TMS as determined by the Transcranial Magnetic Stimulation Adult Safety Screen (TASS) questionnaire;
2. Have a history of a medical or neurological disorder that affects the central nervous system (e.g., traumatic brain injury, stroke, Parkinson's disease);
3. Are pregnant or breast feeding. TMS is not unsafe in pregnancy and therefore the study team is not requiring a pregnancy test prior to entry. If participants become pregnant during the study they will not be excluded. The study team is not including people who are currently aware of being pregnant as OCD can be affected during the later stages of pregnancy and therefore is a potential confound;
4. Have a history of seizures;
5. Have any metal implants or dentures;
6. Have a serious or unstable medical condition requiring immediate investigation or treatment (e.g., severe or recent cardiac disease);
7. Have a cardiac pacemaker, cochlear implants, implanted electronic devices, non-electronic metallic implants, or other contraindications for rTMS;
8. Take more than 2mg of lorazepam or equivalent benzodiazepine, or any anticonvulsant medication;
9. Fulfill criteria for Alcohol Use Disorder.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Personalized, EEG-triggered rTMS

active comparator: Non-personalized, non-EEG triggered rTMS

Interventions

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.

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.

Primary outcome measure

  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: From screening to the end of the follow-up period (1 week post-intervention) ]

Central Contacts and Locations

Central contacts

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H1

Contacts

Principal Investigator:

Brigitte Zrenner, MD

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Apr 24, 2025

Last verified

Apr, 2025

Keywords

  • Obsessive Compulsive Disorder
  • Treatment Resistant Obsessive Compulsive Disorder
  • Transcranial Magnetic Stimulation
  • Repetitive Transcranial Magnetic Stimulation
  • Electroencephalography
  • Electroencephalography Triggered rTMS
  • EEG-Triggered rTMS
  • OCD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2025-04-24.