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

NCT05964049 | Unknown

• 1 other identifier: CPLOCDDLPFC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder; OCD

Keywords

Obsessive-Compulsive Disorder; OCD; Treatment-resistant OCD

Outcome Measures

Primary Outcomes (1)

• 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;

  Baseline, Day 15(immediate post-treatment), 15- and 30-day post-treatment

Secondary Outcomes (5)

• remission rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  Baseline, Day 15(immediate post-treatment), 15- and 30-day post-treatment

• Partial response rates estimated using Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  Baseline, Day 15(immediate post-treatment), 15- and 30-day post-treatment

• cognitive change in stroop

  Baseline, Day 15(immediate post-treatment)

• cognitive change in Hopkins verbal learning test(immediate recall)

  Baseline, Day 15(immediate post-treatment)

• cognitive change in Trail-Making Test

  Baseline, Day 15(immediate post-treatment)

Study Arms (2)

active rTMS treatment

EXPERIMENTAL

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.

Device: active rTMS treatment

sham control

SHAM COMPARATOR

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.

Device: sham rTMS treatment

Interventions

active rTMS treatment DEVICE

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.

active rTMS treatment

sham rTMS treatment DEVICE

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.

sham control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changping Laboratory: lead

Study Sites (1)

Peking University Six Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Hesheng Liu, Ph.D.

  Changping Laboratory

  STUDY CHAIR

Central Study Contacts

Meiling Li, Ph.D.

CONTACT

010-80726688; meilingli@cpl.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 27, 2023
• Study Start: July 16, 2023
• Primary Completion: July 20, 2024
• Study Completion: October 20, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

CN (1)