Preliminary Explorative Study of Magnetic Resonance-Guided Focused Ultrasound Surgery in Refractory Obsessive-Compulsive Disorder Patients
Preliminary Explorative Study of Magnetic Resonance-Guided Focused Ultrasound Surgery in Refractory Obsessive-Compulsive Disorder Patients
The goal of this clinical trial is to evaluate If magnetic resonance-guided focused ultrasound works to treat refractory obsessive-compulsive disorder in adults. The main questions it aims to answer are:
Participants will:
Inclusion Criteria:
For 30 days before enrollment, the type and dosage of primary OCD medications (including antidepressants and adjunctive medications such as antipsychotics and tricyclic antidepressants) remain unchanged. However, other symptom-relief medications, such as anti-anxiety drugs, are not restricted.
Diagnosed by a psychiatrist through a diagnostic interview, meeting the criteria for OCD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) for at least five years; and scoring above 28 on the Chinese version of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
OCD symptoms show limited improvement with existing treatments, classified as refractory according to the OCD Clinical Practice Review Task Force of the Anxiety & Depression Association of America (ADAA):
i. Received treatment with at least three different antidepressants at adequate doses and durations.
ii. Received treatment with at least two of the following medications for over a month each: antipsychotics, clonazepam, lithium, buspirone.
iii. Underwent appropriate cognitive-behavioral therapy with exposure and response prevention (EX/RP) for at least 20 sessions.
Exclusion Criteria:
- Major and Potential Physical Conditions That May Affect the Treatment Process: i. Cardiovascular or hemodynamic abnormalities, such as heart failure, arrhythmias, tachycardia or bradycardia (>100 bpm, <60 bpm), abnormal systolic blood pressure (>180 mmHg, <90 mmHg), abnormal diastolic blood pressure (>180 mmHg), and severe hypertension uncontrolled by medication (diastolic blood pressure >100 mmHg after stable medication use). Additionally, those who have taken medications affecting autonomic regulation and potentially impacting vital sign stability within six months before treatment (however, antidepressants and antipsychotics taken for mental illness are not included).
ii. Platelet or coagulation disorders or currently taking anticoagulant medications (e.g., Warfarin, Avastin).
iii. Renal dysfunction (eGFR < 30ml/min/1.73 m²) or currently undergoing hemodialysis.
iv. Severe infections. v. Immunocompromised individuals. vi. History of intracranial hemorrhage, intracranial aneurysm, cerebrovascular events within six months, or brain tumors.
vii. Neurological disorders: stroke, epilepsy, suspected increased intracranial pressure (IICP), Parkinson's disease and related disorders (Multisystem atrophy, Progressive supranuclear palsy, Dementia with Lewy bodies, Alzheimer's disease).
viii. Other clinically assessed physical conditions that may pose significant risks to bodily functions and life during the treatment process.