Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT07198594
Eligibility Criteria:
Inclusion Criteria:
* Volunteer subjects with Obsessive Compulsive Disorders (OCD) according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V) criteria
* without associated tics ("Gilles de la Tourette" Syndrome)
* Age 18-60 years, right-handed
* Disease severity: Yale-Brown Obsessive Compulsive Scale score ≥16 for OCD patients
* Medication stable for at least 4 weeks
* Resistant patients to standard treatments: partial but insufficient response (reduction of Y-BOCS score \< 35%) or lack of response to previous well conducted treatment including: optimal tolerated dose and adequate duration (\> 12 weeks) of at least 2 Serotonin Reuptake Inhibitors (selective serotonin reuptake inhibitors, clomipramine), or 1 Serotonin Reuptake Inhibitors + 1 augmentation strategy (adjunction of an antipsychotic - such as risperidone or olanzapine or aripiprazole - or lithium or buspirone)
* No systematic rTMS therapy in the past six months;
* Signature of informed consent form;
* Normal vision or corrected vision;
* Capacity to complete protocol-specified tests.
Exclusion Criteria:
* Abnormal cognitive status (assessed using MoCA with score \<24);
* Other primary diagnosis than OCD (comorbid mild depression is tolerated)
* Comorbid diagnosis of schizophrenia/ psychotic disorder, bipolar disorder, substance abuse or dependance3)
* Significant self-harm intent or severe suicidal tendencies within the past year;
* Irreversible visual or auditory impairment preventing completion of scales or related assessments;
* Presence of metallic implants, such as pacemakers or stents;
* Any current or potential medical, psychological, social, or geographical factors compromising patient safety or study participation;
* Poor compliance;
* Claustrophobia;
* History of epilepsy or familial epilepsy
* Pregnant or lactating women (women of childbearing potential must obtain a negative pregnancy test result prior to study commencement and employ medically approved contraceptive measures);
* Deterioration or failure of vital organ function (cardiac, pulmonary, hepatic, renal, etc.); or unstable vital signs;
* Conditions unsuitable for this stimulation site, such as increased intracranial pressure, elevated intraocular pressure, or glaucoma
* History of or concomitant neurological disorders: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease and Parkinson's disease, Lewy body dementia, traumatic brain injury dementia, other physical/chemical factors (drugs, alcohol, CO, etc.), significant somatic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural haematoma, brain tumours), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiency or any other cause
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07198594
Study Brief:
Protocol Section:
NCT07198594