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.
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 efficacy of different intervention targets (DMPFC, DLPFC, OFC, SMA) and found that targeting the anterior part of the right SMA in patients yielded the best response rates for individuals with obsessive-compulsive disorder (OCD) while targeting the DLPFC showed poor efficacy. However, the preSMA is a large region, and different nodes within this region have distinct functional connections with other areas. Thus, precise localization of neural circuitry implicated in OCD symptomatology is essential for achieving effective therapeutic interventions. Leveraging an innovative technique pBFS, the current study aims to identify individual-specific preSMA targets with functional connectivity to the attention network, enabling a more personalized and targeted approach to diagnosis and treatment for OCD patients. A novel high-dose treatment modality known as SAINT received approval from the U.S. FDA in September 2022 for managing the treatment-resistant major depressive disorder. Building upon these findings, this study hypothesizes that high-dose iTBS targeting the preSMA guided by pBFS will have a significant therapeutic effect on 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 5-day rTMS modulation and a 1-month, 2-month 3-month follow-up visit. Patients will have a stable treatment regimen during the 5-day treatment and one-month post-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Participants will receive 10 sessions per day of 1800 pulses per session, lasting for 5 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.
response 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. This research compared the response rates of Y-BOCS between groups using non-parametric rank-sum tests to assess improvement immediately post-intervention. Response is defined as a symptom improvement ≥35% on these scales;
Time frame: Baseline, Day 5, one-month post-treatment
remission rate estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Remission was defined as a score \<8.
Time frame: Baseline, Day 5, one-month post-treatment, two-month post-treatment, three-month 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 5, one-month post-treatment,two-month post-treatment, three-month 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 5
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 5
cognitive change in Trail-Making Test
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The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning
Time frame: Baseline, Day 5