Clinical trial NCT06692114: Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of OCD
Official title: A Preliminary Study on the Efficacy and Influencing Factors of Deep Transcranial Magnetic Stimulation in the Treatment of Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: deep transcranial magnetic stimulation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: This study aims to explore the efficacy and influencing of accelerated dTMS (deep Transcranial Magnetic Stimulation) treatment in patients with obsessive-compulsive disorder (OCD), and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).

Detailed description: The study is to recruit eligible patients with obsessive-compulsive disorder (OCD) from the Shanghai Mental Health Center for deep transcranial magnetic stimulation (dTMS) intervention, and recruit healthy controls who meet the enrollment criteria from the community. Among them, patients with OCD will be randomly divided into a real stimulation group and a sham stimulation group. After baseline assessment, dTMS treatment will be administered twice a day. EEG data collection, MRI data, cognitive tasks, psychological self-assessment scales and clinical symptom assessment will be conducted before treatment and 2 weeks after treatment. During the treatment process, patients will receive two treatments per day, each lasting 20 minutes, for a total of 2 weeks, or 28 treatments in total.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 50, both genders are welcome.
* DSM-5 criteria for OCD.
* Y-BOCS total score ≥ 16 despite therapeutic-dose SRI treatment or completion of at least one full course of CBT. The treatment regimen must have been stable for at least 8 weeks prior to enrollment and remain unchanged throughout the study.
* More than 9 years of education.
* Right-handed.

Exclusion Criteria:

* Any additional current psychiatric comorbidity, except for obsessive- compulsive personality disorder.
* Severe obsessive symptoms prevent the completion of necessary assessments.
* Has a history of receiving ECT therapy.
* Has received rTMS or tDCS treatment within the past two months.
* Has severe physical illnesses or any physical conditions that can induce epilepsy or intracranial hypertension, including cardiovascular and respiratory diseases, among others.
* Has a past history of neurological disorders (such as epilepsy, cerebrovascular accidents, etc.) or brain injuries, or a history of brain surgery.
* Has implanted medical devices such as intracranial stents, cardiac pacemakers, coronary stents, cochlear implants, etc.
* Serious suicide risk.
* Pregnancy or nursing of an infant.

Primary outcomes:
measure: Change in symptom improvement assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS）
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Change in The Beck Depression Inventory (BDI)
timeFrame: Up to 6 weeks
measure: Change in the The Beck Anxiety Inventory (BAI)
timeFrame: Up to 6 weeks
Other outcomes:
measure: The influence of NEO Five-Factor Inventory-Revised on OCD
timeFrame: Baseline
measure: Attention Network Task (ANT)
timeFrame: Up to 2 weeks
measure: Rapid Serial Visual Presentation (RSVP)
timeFrame: Up to 2 weeks
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Study Principal Investigato
name: Zhen Wang, PhD，MD
role: PRINCIPAL_INVESTIGATOR
References: