Obsessive-Compulsive Disorder
Conditions
Brief summary
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.
Interventions
DEVICERepetitive transcranial magnetic stimulation
Non invasive brain stimulation
Sponsors
Amsterdam UMC, location VUmc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| task based functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) response | Baseline and 12 weeks (i.e. post-treatment) | Change in task based fMRI BOLD response following rTMS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up) | OCD symptom severity |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cortical excitation and inhibition (Motor-evoked potential amplitude, TMS-evoked potential, short interval cortical inhibition, long interval cortical inhibition) | Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up) | Measured using single and double pulse TMS + electromyography (EMG) / electroencephalography (EEG) |
| Neurotransmitter concentrations | Baseline and 12 weeks (i.e. post-treatment) | Measured using magnetic resonance spectroscopy (MRS) |
| Planning | Baseline, 12 weeks (i.e. post-treatment) | Measured using Tower of London cognitive task |
| Functional connectivity | Baseline and 12 weeks (i.e. post-treatment) | Measured using resting state fMRI |
| Error processing | Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up) | Measured using the Flanker cognitive task |
| EEG measures | Baseline, 6 weeks, (i.e. during treatment), 12 weeks (i.e. post-treatment), 22 weeks (i.e. follow-up) | Resting state EEG, EEG event related potentials measured during tasks (Error related negativity using Flanker task, Late Positive Potential during appraisal of emotional stimuli) |
| Response inhibition | Baseline, 12 weeks (i.e. post-treatment) | Measured using the stop-signal cognitive task |
| Structural connectivity | Baseline and 12 weeks (i.e. post-treatment) | Measured using diffusion tensor imaging (DTI) MRI |
Countries
Netherlands
Outcome results
None listed