TMS-induced Plasticity Improving Cognitive Control in OCD

Study Overview
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Brief Summary
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Repetitive transcranial magnetic stimulation (rTMS) has been shown in several previous clinical trials to be an effective treatment for obsessive-compulsive disorder (OCD). However, the neural working mechanisms of rTMS in OCD are unknown, and the optimal stimulation sites have not yet been established. Our study aims to compare the clinical and neurobiological effects of three different rTMS stimulation protocols in OCD patients. 8 weeks of rTMS therapy will be delivered in combination with cognitive behavioural therapy. Multimodal neuroimaging will be carried out before and after treatment in order to demonstrate the neurobiological effects of the therapy.

Official Title
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Transcranial Magnetic Stimulation (TMS)-Induced Plasticity Improving Cognitive Control in Obsessive-compulsive Disorder (OCD)

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Device: Repetitive transcranial magnetic stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OCD patients: Age between 18 and 65 Primary DSM-5 diagnosis of OCD Moderate to severe OCD symptoms (expressed as a minimum score of 16 on the Yale - Brown Obsessive Compulsive Scale (YBOCS) Unmedicated or stable dose of medication for at least 12 weeks prior to randomisation - with no plans to change dose during the study period At least 1 previous attempt at cognitive behavioural therapy (CBT) in lifetime At least 1 previous attempt with serotonergic medication or strong preference for non-pharmacological treatment Capacity to provide informed consent Healthy controls (baseline measurements only): Age between 18 and 65 Capacity to provide informed consent Exclusion Criteria: OCD patients: MRI exclusion criteria (metal in body, pregnancy) TMS exclusion criteria (metal in body, history of epilepsy) Schizophrenia, bipolar disorder, active suicidal ideation, use of antipsychotics within last 12 weeks previous experience with rTMS as treatment Healthy controls: Current Diagnostic and Statistical Manual (DSM)-5 diagnosis Personal history of DSM-5 diagnosis use of psychotropic medications within last 12 months 1st degree family member with OCD MRI exclusion criteria (as above) TMS exclusion criteria (as above)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS condition 1<br> | Device: Repetitive transcranial magnetic stimulation<br>* Non invasive brain stimulation<br>* Other names: rTMS, TMS;|
| Experimental: rTMS condition 2<br> | Device: Repetitive transcranial magnetic stimulation<br>* Non invasive brain stimulation<br>* Other names: rTMS, TMS;|
| Experimental: rTMS condition 3<br> | Device: Repetitive transcranial magnetic stimulation<br>* Non invasive brain stimulation<br>* Other names: rTMS, TMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response | Change in task based fMRI BOLD response following rTMS | Baseline and 12 weeks (i.e. post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | OCD symptom severity | Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up) |