TMS-induced plasticity improving cognitive control in OCD

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 85

Inclusion Criteria

OCD patients:
- Age between 18 and 65
- Primary DSM-5 diagnosis of OCD (established by the SCID-I) (comorbid
diagnoses of depression and other anxiety disorders allowed)
- 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 CBT in lifetime (minimum of 8 sessions
completed)
- At least 1 previous attempt with serotonergic medication (SSRI or
clomipramine, minimum 12 weeks (or 3 weeks if stopped due to side effects)) or
strong preference for non-pharmacological treatment
- Capacity to provide informed consent
- Suitability to participate in the trial as assessed by including
clinician, Healthy controls (baseline measurements only):
- Age between 18 and 65
- Capacity to provide informed consent

Exclusion Criteria

OCD patients:
- MRI exclusion criteria: pregnancy, iron in the body, metal in the teeth,
claustrophobia, any known neurological diseases (including epilepsy), previous
brain surgery, head trauma that resulted in unconsciousness for at least 1 hour
- TMS exclusion criteria: metallic implanted devices (e.g. pacemakers,
cochlear implants), epilepsy, family history of epilepsy (1st degree family
member), any known neurological disorder that causes a lesion to the brain
(multiple sclerosis, previous serious head trauma, stroke, etc), pregnancy,
breastfeeding, use of pro-convulsive medications or medication affecting
cortical excitability (e.g. anti-epileptics, benzodiazepines, antihistamines),
syncope, severe heart disease, sleep deprivation, comorbid substance
use/abuse/dependence (including alcohol), resting motor threshold >75% of
maximum stimulator output, or no useful MEP elicitable.
- Schizophrenia, bipolar disorder, active suicidal ideation, use of
antipsychotics within last 12 weeks
- previous experience with rTMS as treatment, Healthy controls (baseline
measurements only):
- Current DSM-5 diagnosis (established by the SCID-I)
- Personal history of DSM-5 diagnosis, except for depression or anxiety
disorder longer than 12 months ago
- No use of psychotropic medications within last 12 months
- 1st degree family member with OCD
- MRI exclusion criteria (as above)
- TMS exclusion criteria (as above)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter is change in tbfMRI blood-oxygen level dependent (BOLD)<br /><br>response following rTMS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameter: Changes in clinical outcomes<br /><br><br /><br>Exploratory objectives<br /><br>• To characterise and compare other neurobiological changes following different<br /><br>rTMS protocols in OCD using multimodal neuroimaging: to include:<br /><br>- Functional connectivity<br /><br>- Structural connectivity<br /><br>- Neurotransmitter concentrations<br /><br>- Cortical excitation and inhibition<br /><br>• To characterise and compare cognitive changes following different rTMS<br /><br>protocols, specifically:<br /><br>- Planning<br /><br>- Response inhibition<br /><br>- Emotion regulation<br /><br>- Error processing<br /><br>• To relate changes in neuroimaging measures to changes in clinical/cognitive<br /><br>measures in order to identify underlying mechanisms<br /><br>• To identify baseline clinical, cognitive and neuroimaging factors that<br /><br>predict degree of response to rTMS + ERP treatment.</p><br>