Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06942559

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

Led by Centre for Addiction and Mental Health · Updated on 2025-04-24

48

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying obsessive compulsive disorder (OCD) to compare two types of repetitive transcranial magnetic stimulation (rTMS) treatments. They aim to see how personalized, EEG-triggered rTMS affects OCD symptoms and brain activity compared to non-personalized, standard rTMS. This study follows a prospective, randomized, single-blind design at the Centre for Addiction and Mental Health and focuses on clinical effects and changes in brain signals related to OCD. Participants receive treatment five days a week for six weeks, totaling 30 sessions. Both groups get rTMS targeting the dorsomedial prefrontal cortex with the same coil, intensity, and pulse number. The personalized group receives EEG-triggered rTMS pulses synchronized to brain waves, while the other group gets standard non-EEG triggered rTMS at high frequency. Each session lasts about 17 minutes. Throughout the study, researchers measure OCD symptoms using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the Obsessive Compulsive Inventory - Revised (OCI-R), and the Clinical Global Impressions - Improvement (CGI-I) scale. They also track changes in EEG brain wave patterns. Assessments occur from screening through one week after treatment ends. Participants' safety and adherence are monitored during this time, with the total involvement lasting about seven weeks.

CONDITIONS

Brief Title

Brain-Oscillation Synchronized Stimulation of the DMPFC

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Are 18-65 years old
  • Have OCD as a primary disorder confirmed by a MINI diagnosis
  • Treatment resistant defined as failure of at least one course of cognitive-behavioural therapy or one SSRI trial
  • Do not meet criteria for substance use disorder except nicotine and caffeine
  • Have a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score above 20
  • Are fluent in English (spoken, written, reading)
  • Have had no increase or start of psychotropic medication in the 4 weeks before screening
  • Have capacity to provide informed consent
  • Willing to sign informed consent form
  • Willing to comply with all study procedures
Not Eligible

You will not qualify if you...

  • Have any contraindications to TMS as determined by the TASS questionnaire
  • Have a history of medical or neurological disorders affecting the central nervous system (e.g., traumatic brain injury, stroke, Parkinson's)
  • Are currently pregnant or breastfeeding
  • Have a history of seizures
  • Have metal implants or dentures
  • Have serious or unstable medical conditions needing immediate treatment
  • Have cardiac pacemakers, cochlear implants, implanted electronic devices, or other contraindications for rTMS
  • Take more than 2mg of lorazepam or equivalent benzodiazepine, or any anticonvulsant medication
  • Meet criteria for Alcohol Use Disorder

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 weeks

Participants receive personalized or non-personalized repetitive transcranial magnetic stimulation (rTMS) sessions targeting the dorsomedial prefrontal cortex.

5 visits per week for a total of 30 sessions

Follow-up

Duration - 1 week

Participants are monitored for clinical and neurophysiological outcomes after completing treatment.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M6J 1H1

Actively Recruiting

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Research Team

B

Brigitte Zrenner, MD

N

Nina E. Bahl, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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