Obsessive-compulsive disorder
Conditions
Interventions
Therapeutic group:Stable medication regimen and MRgFUS therapy
Sponsors
West China Xiamen Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with obsessive-compulsive disorder (OCD) according to the American Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Revision (DSM-5-TR), with a history of at least 3 years and significant functional impairment due to OCD. 2. The score on the Yale-Brown Obsessive-Compulsive Disorder Scale (Y-BOCS) = 25 points. 3. Age >=18 years old, <=65 years old. 4. 5 years or more of education. 5. Patient is willing to participate in all study follow-up visits and able to sign informed consent, as determined by the psychiatrist and MRgFUS treating physician participating in the study. 6. Obsessive-compulsive disorder symptoms that cannot be improved or have limited improvement through existing treatments (Y-BOCS deduction rate <35%), as determined by the psychiatrist participating in the study based on the evaluation of adequate doses and courses of standard psychiatric treatment, including medication and psychotherapy, specific criteria include: (1) Antidepressant medication: The patient has received at least three or more recognized first-line medications for OCD, such as selective serotonin reuptake inhibitors (SSRIs, such as fluoxetine, citalopram), Selective serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs, such as clomipramine) or other antidepressants and complete an adequate course of treatment for 8 to 12 weeks, including the maximum tolerated dose lasting 4 to 6 weeks; (2) Synergistic therapy: If the patient can tolerate it, try at least two synergistic and adjuvant therapies, including second-generation antipsychotics, for a duration of not less than one month; (3) Psychotherapy: Patients have received at least 12 adequate sessions of cognitive behavioral therapy (CBT) provided by experienced psychotherapists; (4) Special circumstances: Patients who cannot tolerate drug treatment or cannot participate in psychotherapy can also be included in the study. 7. Ability to locate bilateral internal capsule forelimbs with the MRgFUS device (internal capsule forelimbs must be evident on MRI for positioning under direct vision). 8. Ability to express sensations during treatment with ExAblate MRgFUS. 9. Medication regimen for OCD must be stable for at least 30 days prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Severe cognitive impairment. 2. Suffering from a mental disorder or bipolar disorder, or having suicidal tendencies (as measured by a HAMD item 3 score of 4 or a high risk of suicide as measured by the Baker Suicidal Ideation Scale (SSI)). Subjects with chronic anxiety or depression, provided their medication has been stable for at least 3 months prior to enrollment and is considered appropriately managed by their psychiatrist. 3. Diagnosed with DSM-5-TR substance use disorder within the past 6 months. 4. Patients with unstable cardiac status (e.g., unstable angina pectoris on medication; Patients who are taking medication (other than diuretics); Patients who are taking antiarrhythmic drugs; Severe hypertension (diastolic blood pressure > 100 while taking medication). 5. Cerebrovascular disease (e.g., CVA within 6 months), history of intracranial hemorrhage or intracranial aneurysm requiring treatment, or arteriovenous malformation (AVM) requiring treatment. 6. Untreated, uncontrolled sleep apnea. 7. Patients with brain tumors, epilepsy, neurodegenerative diseases, or any other major neurological diseases. 8. Patients with standard contraindications to MRI imaging, such as implantation of non-MRI compatible metal devices (including pacemakers), size limitations, etc. 9. Known intolerance or allergy to MRI contrast agents (e.g., gadolinium or magvexian), including advanced renal disease. 10. Subjects who weigh more than the upper limit of the MRI scanner table weight and cannot fit into the MRI scanner. 11. Overall cranial density ratio calculated from screening CT less than 0.40. 12. Severely impaired renal function (estimated glomerular filtration rate <30ml/min/1.73m2) or undergoing dialysis. 13. Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR). 14. Current medical condition causing abnormal bleeding and/or coagulopathy. 15. Treatment with anticoagulants (such as warfarin) or antiplatelet (such as aspirin) within one week of focused ultrasonography or medications known to increase the risk of bleeding within one month after focused ultrasonography. Receiving medications or supplements that increase the risk of bleeding, such as NSAIDs, ginkgo biloba extract, and ginseng, within one week of focused ultrasound. 16. Individuals who are unable or unwilling to tolerate the prolonged stationary supine position required during treatment. 17. Is participating in or has participated in another clinical trial within the past 30 days. 18. Patient is unable to communicate with the investigator and staff. 19. Currently pregnant (as determined by medical history and serum HCG) or lactating. 20. Life-threatening systemic diseases (including but not limited to the following) will be excluded from the study: HIV, liver failure, blood disorders, etc. 21. Other situations that the investigator considers unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Yale-Brown Obsessive-Compulsive Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale;Clinical Global Impression;Global Assessment Function;Hamilton Anxiety Scale; | — |
Countries
China
Contacts
Public ContactGong Qiyong
West China Xiamen Hospital of Sichuan University
Outcome results
None listed