rTMS Over the Supplementary Motor Area for Treatment-resistant Obsessive-compulsive Disorder. (rTMSOCD)
Obsessive-Compulsive Disorder
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, TMS
Eligibility Criteria
Inclusion Criteria:
- age between 18 and 65 yy
- DSM-5 criteria for OCD
- Y-BOCS total score > or = 20
- History of treatment-resistant OCD, established by a trained psychiatrist with extensive expertise in the OCD field. Treatment-resistance is defined as non-response (less than 25% reduction of the Y-BOCS score) after at least one SRIs trials (clomipramine, fluoxetine, sertraline, paroxetine, fluvoxamine, citalopram, escitalopram) at the maximum tolerable dose for at least 12 weeks.
Exclusion Criteria:
- any additional current psychiatric comorbidity, except for mild depressive and anxious symptoms or tics;
- a lifetime DSM-5 diagnosis of schizophrenia or other psychotic syndromes, substance dependence or substance abuse, including alcohol, bipolar I or II disorder, mental disorder due to a general medical condition;
- serious suicide risk;
- episodic OCD;
- illness duration less than two years
- hospitalization in the last 6 months;
- refractory OCD (defined as non response to two SRIs trials, one antidopaminergic augmentation and at least one CBT with ERP trial);
- patient who did not response to a previous ECT trial;
- the inability to receive rTMS because of metallic implants, or history of seizures (personal or family history of seizure in first degree relatives);
- any major medical disease;
- pregnancy or nursing of an infant;
- the inability or refusal to provide written informed consent.
Sites / Locations
- Stefano PallantiRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active rTMS
Sham rTMS
Active stimulation parameters will be 1-Hz, 10 seconds per train, 10 pulses per train (3 seconds inter-train interval) for a total of 160 trains (1600 pulses/session) at 130% of resting motor threshold (MT) (using the lowest value of the dominant hemisphere), once a day, 5 day/week, for 3 weeks. The coil will be positioned over the pre-SMA, targeted using the International 10-20 EEG System. Pre-SMA is defined at 15% of the distance between inion and nasion anterior to Cz (vertex) on the sagittal midline. The coil will be placed with the handle along the sagittal midline, pointing towards the occiput to stimulate bilaterally and simultaneously the pre-SMA.
Sham TMS will be administered by tilting the coil 90° off the scalp, with one wing of the coil touching the scalp. This sham-TMS approach produces a clicking sound that is very similar to an active TMS pulse and induces a voltage in the brain that is more than 75% lower than active TMS.