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pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Obsessive-Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder, OCD

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
active rTMS treatment
sham rTMS treatment
Sponsored by
Changping Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, Treatment-resistant OCD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    active rTMS treatment

    sham rTMS treatment

    Arm Description

    10 sessions of active rTMS would be delivered to the right preSMA daily, with a session of 1800 pulse.

    5 sessions of sham rTMS would be delivered to the right preSMA daily, with a session of 1800 pulse.

    Outcomes

    Primary Outcome Measures

    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;

    Secondary Outcome Measures

    remission rate estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
    Remission was defined as a score <8.
    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;
    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.
    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
    cognitive change in Trail-Making Test
    The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    July 19, 2023
    Sponsor
    Changping Laboratory
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05964062
    Brief Title
    pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
    Official Title
    Personalized Brain Functional Sectors (pBFS) Guided High-dose rTMS Therapy for Treatment-resistant Obsessive-Compulsive Disorder: A Randomized, Double-Blind, Sham-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 20, 2023 (Anticipated)
    Primary Completion Date
    July 20, 2024 (Anticipated)
    Study Completion Date
    October 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changping Laboratory

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder, OCD
    Keywords
    Obsessive-Compulsive Disorder, Treatment-resistant OCD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    active rTMS treatment
    Arm Type
    Experimental
    Arm Description
    10 sessions of active rTMS would be delivered to the right preSMA daily, with a session of 1800 pulse.
    Arm Title
    sham rTMS treatment
    Arm Type
    Sham Comparator
    Arm Description
    5 sessions of sham rTMS would be delivered to the right preSMA daily, with a session of 1800 pulse.
    Intervention Type
    Device
    Intervention Name(s)
    active rTMS treatment
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    sham rTMS treatment
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    response rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    remission rate estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
    Description
    Remission was defined as a score <8.
    Time Frame
    Baseline, Day 5, one-month post-treatment, two-month post-treatment, three-month post-treatment
    Title
    partial response rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
    Description
    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
    Title
    cognitive change in Stroop
    Description
    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
    Title
    cognitive change in Hopkins verbal learning test(immediate recall)
    Description
    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
    Title
    cognitive change in Trail-Making Test
    Description
    The test can provide information about visual search speed, scanning, speed of processing, mental flexibility, and executive functioning
    Time Frame
    Baseline, Day 5

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Meiling Li, Ph.D.
    Phone
    010-80726688
    Email
    meilingli@cpl.ac.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hesheng Liu, Ph.D.
    Organizational Affiliation
    Changping Laboratory
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    pBFS Guided High-dose rTMS Therapy for Treatment-Resistant Obsessive-Compulsive Disorder

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