The investigators aim to evaluate the safety and efficacy of pBFS-guided rTMS therapy targeting DLPFC for patients with treatment-resistant Obsessive-Compulsive Disorder.
In 2018, rTMS received approval from the U.S. Food and Drug Administration (FDA) for the treatment of OCD. Based on randomized clinical trials, researchers have observed significant variations in the intervention effects when targeting the dorsolateral prefrontal cortex (DLPFC), which is a large region with different subregions and functional connections to other areas across multiple functional networks. Precise targeting of neural circuitry related to OCD symptoms is crucial for effective intervention. The ventrolateral prefrontal cortex and insula are key components of the OCD functional circuitry within the ventral attention/salience network. However, stimulating these brain regions with TMS is challenging, and patients often have a low tolerance. Previous studies have found that effective targets for various interventions used in psychiatric disorders are located within the same functional circuitry. Therefore, in this study, The investigator employed the pBFS technique to precisely locate the DLPFC subregions within the ventral attention/salience network. The investigator hypothesizes that rTMS intervention targeting the DLPFC guided by pBFS will significantly alleviate clinical symptoms in treatment-resistant OCD patients. After being informed about the study and potential risks. All patients giving written informed consent will undergo a screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner in a 2:1 ratio to the active rTMS group, or sham-control group. Then all participants will undergo a 15-day （3 weeks， treatment on weekdays） rTMS modulation. After treatment, 15-, 30-, 60-, and 90-day follow-up visits will occur. Participants will keep a stable treatment regimen during the intervention and the first-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Participants will receive 5 sessions per day of 1800 pulses per session, lasting for 15 days. Individualized targets will be generated using the pBFS method.
The parameters in the sham arms are the same as the active stimulation groups. Stimulation was delivered by the same device as the active group fitted with a sham coil.
Peking University Six Hospital
Beijing, Beijing Municipality, China
RECRUITINGresponse rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
The Y-BOCS is a validated instrument stratifying the severity of obsessive episodes. This validated questionnaire was used to assess the response rate and remission rate of obsessive episodes. The response is defined as a symptom improvement of ≥35% on Y-BOCS;
Time frame: Baseline, Day 15(immediate post-treatment), 15- and 30-day post-treatment
remission rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Remission was defined as a score \<8.
Time frame: Baseline, Day 15(immediate post-treatment), 15- and 30-day post-treatment
Partial response rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Partial response is defined as a symptom 35% ≥ improvement ≥25% on Y-BOCS
Time frame: Baseline, Day 15(immediate post-treatment), 15- and 30-day post-treatment
cognitive change in stroop
The Stroop test can be used to measure a person's selective attention capacity and skills, processing speed, and alongside other tests to evaluate overall executive processing abilities
Time frame: Baseline, Day 15(immediate post-treatment)
cognitive change in Hopkins verbal learning test(immediate recall)
The Hopkins Verbal Learning Test (HVLT-R) is one such assessment that consists of memorization of a list of words to test the ability to recall immediately after memorization
Time frame: Baseline, Day 15(immediate post-treatment)
cognitive change in Trail-Making Test
The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning
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Time frame: Baseline, Day 15(immediate post-treatment)