Obsessive-compulsive disorder Mental and Behavioural Disorders
Conditions
Interventions
Patients diagnosed with OCD will be included in the study.
Visit -1 (-20 - 0 days):
Anamnesis, including demographic data and medical history, checking the adequate maintenance treatment.
Yale-Brown
28 sessions in 6 weeks. Placebo: sham-dTMS applied to mPFC
28 sessions in 6 weeks.
All mPFC-dTMS applications will be preceded by OCD symptoms provocation for five minutes before the start of the mPFC-rTMS/sham session (according to FDA protocol for rTMS in O
Sponsors
Ministry of Health
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female outpatients aged 18-70 years; 2. Meeting DSM-V criteria for OCD; 3. Patients having completed at least one unsuccessful but adequate antidepressant treatment according to criteria for treatment-resistant OCD (treatment history is sufficient); 4. Being able to understand and sign the Informed Consent Form; 5. Being on a stable and adequate dose of antidepressants and/or antipsychotics (monotherapy or combination) for at least eight weeks before the commencement of dTMS, if used. 6. Y-BOCS score =20 corresponding to the Severity scale = three on Clinical Global Impression on the initial visit.
Exclusion criteria
Exclusion criteria: 1. Psychiatric comorbidity on axis I and II according to DSM V six months before enrollment to the study except for depressive, anxiety, and obsessive-compulsive related disorders; 2. Personality disorder that makes participation in the trial difficult; 3. History of substance dependence in the last year except for nicotine; 4. Contraindications of rTMS/dTMS treatment; 5. Pregnancy or breast-feeding; 6. Patients with severe somatic disorders (cardiovascular disease, neoplasms, endocrinology disorders, etc.); 7. Patients treated with electroconvulsive therapy less than three months before enrollment or suffering from neurologic disorder (e.g., epilepsy, head trauma with loss of consciousness) and patients using any treatment that can strongly affect EEG; 8. Substantial suicidal risk as judged by the treating psychiatrist; 9. Sensory and motor impairment precluding the participation in computer tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuronal predictors of therapeutic success of mPFC-dTMS in OCD patients using MRI by evaluating pre- and post-treatment dTMS-mPFC changes in grey matter (GM) in the anterior cingulate cortex (ACC), mPFC, OFC, and striatum, and WM in selected tracts and bundles using fMRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcomes as of 26/01/2026: Neuronal predictors of therapeutic success of mPFC-dTMS in OCD patients using EEG and MRI by evaluating pre- and post-treatment dTMS-mPFC changes in: 1. EEG resting state oscillations; 2. ERN during the Flanker task; 3. Resting-state FC of the ACC, striatum, and the prefrontal cortex (PFC)/OFC 4. Functional MRI (fMRI) activations during the exposure to individual OCD symptom-related visual stimuli and the inhibitory control task. 5. ACC-centred CSTC connectivity and regional E-field strength assessed by E-field modelling and resting-state fMRI as predictors of dTMS-related symptom improvement. Previous key secondary outcomes: Neuronal predictors of therapeutic success of mPFC-dTMS in OCD patients using EEG and MRI by evaluating pre- and post-treatment dTMS-mPFC changes in: 1. EEG resting state oscillations; 2. ERN during the Flanker task; 3. Resting-state FC of the ACC, striatum, and the prefrontal cortex (PFC)/OFC 4. Blood oxygenation level-dependent (BOLD) - functional MRI (fMRI) activations during the exposure to individual OCD symptom-related visual stimuli. | — |
Countries
Czech Republic
Contacts
Public ContactMonika Klírová
Outcome results
None listed