Status:
UNKNOWN
pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
Lead Sponsor:
Changping Laboratory
Conditions:
Obsessive-Compulsive Disorder
OCD
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The research aims to evaluate the safety and efficacy of pBFS-guided High-dose rTMS therapy targeting preSMA for patients with treatment-resistant Obsessive-Compulsive Disorder.
Detailed Description
In 2018, rTMS received approval from the U.S. Food and Drug Administration (FDA) for the treatment of OCD. Based on a systematic meta-analysis of randomized clinical trials, researchers compared the e...
Eligibility Criteria
Inclusion
- Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.
- Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for obsessive-compulsive disorder, and currently experiencing a first or recurrence episode.
- Total Y-BOCS score ≥20 and total HAMD score \<17 before randomization.
- Before randomization, patients must have received a minimum of 2 months of maintenance treatment with SSRI medication prior to randomization, or have undergone maintenance CBT treatment with inadequate response to SSRI medication (less than 50% symptom improvement), or have previously shown inadequate response (less than 50% symptom improvement) to at least one trial of SSRI medication or cognitive-behavioral therapy. Patients currently taking medication should have been on a stable dose for 8 weeks.
- Voluntarily participate in the trial and sign informed consent. Able to comply with the planned visit, examination and treatment plan, and other study procedures.
Exclusion
- Does not meet the inclusion criteria
- Exhibiting hoarding disorder.
- Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia, schizoaffective disorder, post-traumatic stress disorder, bipolar disorder, and secondary depression, etc.);
- Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment;
- History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold;
- History of ECT, rTMS, light therapy within 3 months;
- Patients with organic brain diseases (such as ischemic stroke, cerebral hemorrhage, brain tumor, etc.) and a history of severe brain trauma as judged by the researcher;
- Patients with serious or unstable diseases of the cardiovascular, liver, kidney, blood, endocrine, neurological system, and other systems or organs.
- Female of childbearing potential who plans to become pregnant during the trial. Female that is pregnant or breastfeeding.
- Substance abuse or dependence (including alcohol misuse and drugs) within the past 6 months.
- First-degree relatives have bipolar affective disorder and schizophrenia.
- There is a significant risk of suicide (MADRS item 3 ≥ 3).
- Difficulty or inability to engage in normal communication, understand or follow instructions, and cooperate with treatment and evaluators.
- Patients currently in any clinical trials of other drugs or physical therapy ( DBS, ECT, rTMS).
- Investigators think that was inappropriate to participate.
Key Trial Info
Start Date :
July 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05964062
Start Date
July 20 2023
End Date
October 20 2024
Last Update
July 27 2023
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