Obsessive - Compulsive Disorder, Obsessive Compulsive Disorder (OCD)
Conditions
Brief summary
The goal of this clinical trial is to learn if individualized accelerated repetitive transcranial magnetic stimulation (rTMS) targeting the inferior frontal cortex combined with symptom provocation works to treat obsessive-compulsive disorders (OCD) in adults. It will also learn about the safety of rTMS over right IFC. The main questions it aims to answer are: * Does rTMS using a new individualized IFC target relieve participants' OCD symptoms? * What medical problems do participants have when taking rTMS? Participants will: * Take rTMS six times per day for 5 consecutive days * Visit the clinic once at baseline, the day and four weeks after treatment for checkups and tests
Interventions
OTHERrTMS
individualized rTMS target the IFC with symptom provocation
Sponsors
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OCD Symptom Severity Assessed by Y-BOCS | From Baseline to 6 months after treatment | Change from Baseline to 4 weeks after treatment in OCD Symptom Severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Severity Assessed by HAMD | From baseline to 4 weeks after treatment | — |
| Anxitey Severity Assessed by HAMA | From Baseline to 4 weeks after treatment | — |
| Clinical Efficacy Assessed by CGI | From Baseline to 4 weeks after treatment | — |
| Uncertainty Assessed by IUI and IUS-12 | From Baseline to 4 weeks after treatment | — |
| Safety for rTMS targeting IFC | Adverse Events after treatment | Number of Participants with Treatment-Related Adverse Events |
| Self-rated State-Trait Anxiety Inventory (STAI) | From Baseline to 4 weeks after treatment | — |
| Self-rated Short UPPS-P Impulsive Behaviour Scale | From baseline to 4 weeks after treatment | — |
| Neuroimaging by Magnetic resonance imaging | From baseline to 4 weeks after treatment | — |
| Cognitive Function Assessent by tasks | From baseline to 4 weeks after treatment | Including Cantab and coded tasks in Matlab |
| Self-rated Beck Depression Inventory (BDI) | From Baseline to 4 weeks after treatment | — |
Countries
China
Contacts
Primary ContactYijie Zhao
Outcome results
None listed