Obsessive Compulsive Disorder (OCD)BOSS-OCDNCT06942559
Brain-Oscillation Synchronized Stimulation of the DMPFC
A study testing EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) and Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Obsessive Compulsive Disorder (OCD) and Treatment Resistant Obsessive Compulsive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD), Treatment Resistant Obsessive Compulsive Disorder
- What is being tested?
- EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) and Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 29 Jan 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 18-65 years old;
- 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;
- Does not meet criteria for substance use disorder as determined by the MINI (with the exception of nicotine and caffeine);
- Have a Y-BOCS score >20;
- Are fluent in the English language (spoken, written, reading);
- Have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening;
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- Must be deemed to have capacity to provide informed consent;
- Must sign and date the informed consent form;
- Stated willingness to comply with all study procedures.
Who cannot join
- Have any contraindications to TMS as determined by the Transcranial Magnetic Stimulation Adult Safety Screen (TASS) questionnaire;
- Have a history of a medical or neurological disorder that affects the central nervous system (e.g., traumatic brain injury, stroke, Parkinson's disease);
- 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;
- Have a history of seizures;
- Have any metal implants or dentures;
- Have a serious or unstable medical condition requiring immediate investigation or treatment (e.g., severe or recent cardiac disease);
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- Have a cardiac pacemaker, cochlear implants, implanted electronic devices, non-electronic metallic implants, or other contraindications for rTMS;
- Take more than 2mg of lorazepam or equivalent benzodiazepine, or any anticonvulsant medication;
- Fulfill criteria for Alcohol Use Disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H1
Nina E. Bahl, MSc, 416-535-8501 ext. 30882, nina.bahl@camh.ca
Brigitte Zrenner, MD
About this study
Official title: Brain-Oscillation Synchronized Stimulation of the DMPFC: A Single-Blind Study for Personalized Neuromodulation in OCD
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 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.
- Being tested
- EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS), Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- Obsessive Compulsive Disorder, Treatment Resistant Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Electroencephalography, Electroencephalography Triggered rTMS, EEG-Triggered rTMS, OCD
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Also called Personalized rTMS, EEG-triggered rTMS, Personalized TMS, EEG-triggered TMS
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)Device
Also called Standard rTMS, Standard TMS, rTMS, TMS
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized, EEG-triggered rTMS | Experimental | Not described Receives: Device: EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Non-personalized, non-EEG triggered rTMS | Active comparator | Not described Receives: Device: Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
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.
Measured: From screening to the end of the follow-up period (1 week post-intervention)
Secondary outcomes (3)
Obsessive Compulsive Inventory - Revised (OCI-R)
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.
Measured: From screening to the end of the follow-up period (1 week post-intervention)
Clinical Global Impressions - Improvement (CGI-I) Scale
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.
Measured: From screening to the end of the follow-up period (1 week post-intervention)
Electroencephalography (EEG) Markers of OCD
- Amplitude of frontoparietal theta oscillations in the resting EEG before and after single treatment sessions measured in dB
- the power of TMS-induced oscillations in the theta range throughout the six-week treatment course measured in dB
Measured: From screening to the end of the follow-up period (1 week post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start29 Jan 2025
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The clinical trial uses a prospective, randomized, single-blind, two-arm interventional controlled study design to evaluate two treatment arms at a single study site. We aim to recruit 48 adults with a primary diagnosis of Obsessive Compulsive Disorder (OCD).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brigitte Zrenner, Centre for Addiction and Mental Health
- Investigators
- Brigitte Zrenner, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942559
- Sponsor's protocol ID
- 104-2023
- Acronym
- BOSS-OCD
- Status last verified
- Apr 2025
- First submitted
- 21 Feb 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from this project may be used for future research by internal and/or external project collaborators upon participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-Oscillation Synchronized Stimulation of the DMPFC: A Single-Blind Study for Personalized Neuromodulation in OCD
- ClinicalTrials.gov ID
- NCT06942559
- Acronym / sponsor ID
- BOSS-OCD / 104-2023
- Keywords
- Obsessive Compulsive Disorder, Treatment Resistant Obsessive Compulsive Disorder, Transcranial Magnetic Stimulation, Repetitive Transcranial Magnetic Stimulation, Electroencephalography, Electroencephalography Triggered rTMS, EEG-Triggered rTMS, OCD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The clinical trial uses a prospective, randomized, single-blind, two-arm interventional controlled study design to evaluate two treatment arms at a single study site. We aim to recruit 48 adults with a primary diagnosis of Obsessive Compulsive Disorder (OCD).
| Arm | Type | Receives |
|---|---|---|
| Personalized, EEG-triggered rTMS | Experimental | Device: EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) |
| Non-personalized, non-EEG triggered rTMS | Active comparator | Device: Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Are 18-65 years old;
- 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;
- Does not meet criteria for substance use disorder as determined by the MINI (with the exception of nicotine and caffeine);
- Have a Y-BOCS score >20;
- Are fluent in the English language (spoken, written, reading);
Key exclusion criteria (9 listed)
- Have any contraindications to TMS as determined by the Transcranial Magnetic Stimulation Adult Safety Screen (TASS) questionnaire;
- Have a history of a medical or neurological disorder that affects the central nervous system (e.g., traumatic brain injury, stroke, Parkinson's disease);
- 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;
- Have a history of seizures;
- Have any metal implants or dentures;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)Also: Personalized rTMS, EEG-triggered rTMS, Personalized TMS, EEG-triggered TMSThe 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 | Personalized, EEG-triggered rTMS |
| Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS)Also: Standard rTMS, Standard TMS, rTMS, TMSThe 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. | Device | Non-personalized, non-EEG triggered rTMS |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: From screening to the end of the follow-up period (1 week 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.
3 secondary outcomes
Obsessive Compulsive Inventory - Revised (OCI-R)
Time frame: From screening to the end of the follow-up period (1 week post-intervention)
Clinical Global Impressions - Improvement (CGI-I) Scale
Time frame: From screening to the end of the follow-up period (1 week post-intervention)
Electroencephalography (EEG) Markers of OCD
Time frame: From screening to the end of the follow-up period (1 week post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Yes. De-identified data from this project may be used for future research by internal and/or external project collaborators upon participant consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brigitte Zrenner, MD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG-Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) and Non-EEG Triggered Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Obsessive Compulsive Disorder (OCD) and Treatment Resistant Obsessive Compulsive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brigitte Zrenner, MD (416-535-8501 ext. 34574, brigitte.zrenner@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.