Local research. Human connections. WCR Miami Lakes (786) 483-7856
Back to study searchNCT06942559
RecruitingNCT06942559ClinicalTrials.gov record

Brain-Oscillation Synchronized Stimulation of the DMPFC

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

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Not applicable
Age range
18 years - 65 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
48 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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, Canada. 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

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

Exclusion Criteria:

1. Have any contraindications to TMS as determined by the TASS questionnaire (18);
2. Have a history of a medical or neurological disorder that affects CNS (such as, traumatic brain injury, stroke, Parkinson);
3. Are pregnant or breast feeding. TMS is not unsafe in pregnancy and therefore we are not requiring a pregnancy test prior to entry. If patients become pregnant during the study they will not be excluded. We are not including patients 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 history of seizures;
5. Have any metal implant or dentures;
6. Have serious or unstable medical condition requiring immediate investigation or treatment (e.g. severe or recent cardiac disease);
7. Have cardiac pacemaker, cochlear implants, implanted electronic devices or non- electronic metallic implants or other contraindications for TMS;
8. Taking more than 2mg of lorazepam or equivalent benzodiazepine, or any anticonvulsant medication;
9. Fulfill MINI criteria for Alcohol Use Disorder;
10. Have received any ablative neurological procedure (e.g., focused ultrasound).

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Double masked
Personalized, EEG-triggered rTMS

Not reported in this registry record.

Device: EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)

Non-personalized, non-EEG triggered rTMS

Not reported in this registry record.

Device: Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)

EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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 5ms inter-pulse-interval will be applied at a median inter-burst interval of 2-3s. The therapeutic intervention consists of 30 sessions of 2000 TMS pulses each for a total duration per treatment session of 15-30 minutes.

Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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 (2s on, 18s off) will be delivered. The therapeutic intervention consists of 30 sessions of 2000 TMS pulses each for a total duration per treatment session of 15-30 minutes.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

Time frame: From screening to the end of the follow-up period (1-month post-intervention)

The Y-BOCS is used to (a) qualify OCD symptoms using a symptom checklist and (b) assess their severity using a symptom severity rating scale. The checklist allows the participant to identify the thoughts and behaviours that are part of their OCD. The severity scale assesses five dimensions of obsessions and compulsions: time spent or occupied, interference with functioning or relationships, degree of distress, resistance, and control (i.e., success with resistance). The scale ranges from 0-40; a lower score indicates less severe OCD, while a higher score indicates more severe OCD.

Secondary measures

Obsessive Compulsive Inventory - Revised (OCI-R)

Time frame: From screening to the end of the follow-up period (1-month post-intervention)

The OCI-R is a self-reported 18-item scale that measures symptom severity across six domains of OCD: washing, checking, ordering, neutralizing, obsessing, and hoarding. The scale ranges from 0-72; lower scores indicate less severe OCD (or a subclinical presentation for scores \<21), while higher scores indicate more severe OCD.

Clinical Global Impressions - Improvement (CGI-I) Scale

Time frame: From screening to the end of the follow-up period (1-month post-intervention)

The CGI-I is a clinician-determined assessment that rates change in global clinical presentation (i.e., improvement or worsening) from the baseline presentation on a 7-point scale.

Electroencephalography (EEG) Markers of OCD

Time frame: From screening to the end of the follow-up period (1-week post-intervention)

1. Amplitude of frontoparietal theta oscillations in the resting EEG before and after single treatment sessions measured in dB
2. the power of TMS-induced oscillations in the theta range throughout the six-week treatment course measured in dB

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Centre for Addiction and Mental HealthToronto, Ontario, CanadaRecruiting
Nina E. Bahl, MScCONTACTnina.bahl@camh.ca416-535-8501 30882
Brigitte Zrenner, MDPRINCIPAL_INVESTIGATOR
View location on map ↗

Study team and timeline

Lead sponsor
Centre for Addiction and Mental Health
Study start
Jan 29, 2025 Actual
Primary completion
2029-01 Estimated
Study completion
2029-01 Estimated
First posted
Apr 24, 2025 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Ashley Melichercik, MScCONTACTashley.melichercik@camh.ca416-535-8501 30899
Official study title

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

A HUMAN NEXT STEP

Ask Wellness Clinical Research

Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.

Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026