TMS-induced Plasticity Improving Cognitive Control in OCD

Amsterdam UMC, location VUmc61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Obsessive-Compulsive Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response

Change in task based fMRI BOLD response following rTMS

Time frame: Baseline and 12 weeks (i.e. post-treatment)

Secondary Outcomes

Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

OCD symptom severity

Time frame: Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up)