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pBFS Guided rTMS Therapy for Treatment-resistant Obsessive-Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder, OCD

Status
Recruiting
Phase
Not Applicable
Locations
China
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, OCD, 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: 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, drugs, and other psychoactive substances) in 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 in any clinical trials of other drugs or physical therapy ( DBS, ECT, rTMS) within 1 month before the screening Investigators think that was inappropriate to participate.

Sites / Locations

  • Peking University Six HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

active rTMS treatment

sham control

Arm Description

5 sessions of active rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse and inter-session interval of 20 min.

5 sessions of sham rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse and inter-session interval of 20 min.

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. The response is defined as a symptom improvement of ≥35% on Y-BOCS;

Secondary Outcome Measures

remission rates 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 10, 2023
Last Updated
July 19, 2023
Sponsor
Changping Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT05964049
Brief Title
pBFS Guided rTMS Therapy for Treatment-resistant Obsessive-Compulsive Disorder
Official Title
Personalized Brain Functional Sectors (pBFS) Guided 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
Recruiting
Study Start Date
July 16, 2023 (Actual)
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 investigators aim to evaluate the safety and efficacy of pBFS-guided rTMS therapy targeting DLPFC 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 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.

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, OCD, 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
5 sessions of active rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse and inter-session interval of 20 min.
Arm Title
sham control
Arm Type
Sham Comparator
Arm Description
5 sessions of sham rTMS would be delivered to the left DMPFC daily, with a session of 1800 pulse and inter-session interval of 20 min.
Intervention Type
Device
Intervention Name(s)
active rTMS treatment
Intervention Description
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.
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. 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
Secondary Outcome Measure Information:
Title
remission rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Description
Remission was defined as a score <8.
Time Frame
Baseline, Day 15(immediate post-treatment), 15- and 30-day 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 15(immediate post-treatment), 15- and 30-day 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 15(immediate post-treatment)
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 15(immediate post-treatment)
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 15(immediate post-treatment)

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: 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, drugs, and other psychoactive substances) in 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 in any clinical trials of other drugs or physical therapy ( DBS, ECT, rTMS) within 1 month before the screening 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
Facility Information:
Facility Name
Peking University Six Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinmin Liao

12. IPD Sharing Statement

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pBFS Guided rTMS Therapy for Treatment-resistant Obsessive-Compulsive Disorder

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