Obsessive-Compulsive Disorder
Conditions
Keywords
deep transcranial magnetic stimulation
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.
Interventions
DEVICEDeep Transcranial Magnetic Stimulation, DTMS active
The treatment plan is to perform 2 treatments per day for 20 minutes each time, for a total of 28 treatments. Each treatment stimulates at a frequency of 20 Hz for 2 seconds, with a sequence interval of 20 seconds. Each treatment consists of 50 sequences, for a total of 2000 pulses.
DEVICEDeep Transcranial Magnetic Stimulation, DTMS sham
The treatment plan is to perform 2 treatments per day for 20 minutes each time, for a total of 28 treatments. Compared with active treatment, the sham stimulation coil only produced sound and scalp vibration.
Sponsors
Zhen Wang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged between 18 and 50, both genders are welcome. * DSM-5 criteria for OCD. * Y-BOCS total score ≥ 20 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD | baseline,2weeks,4weeks | It assesses the severity of OCD symptoms. The Y-BOCS scale ranges from 0 to 40, with 0 being no symptoms and 40 being severe. The primary outcome measure percent reduction of Y-BOCS scores at completion of the dTMS treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To explore the differences in treatment efficacy between active and sham dTMS in patients with OCD | baseline,2 weeks, 4 weeks | The secondary outcome measure was the response rate to the treatment, which was defined as a reduction of at least 35% in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) |
| Change in The Beck Depression Inventory (BDI) | baseline,2 weeks, 4 weeks | It is a 21-item self-report measure scored on a 4-point Likert-type scale to summarize recent symptoms of depression. |
| Change in the The Beck Anxiety Inventory (BAI) | baseline,2 weeks, 4 weeks | It is a 21-item self-report inventory that is used for measuring the severity of anxiety |
Other
| Measure | Time frame | Description |
|---|---|---|
| Attention Network Task (ANT) | Up to 2 weeks | Have patients allocate their attention and process information through tasks processed by a grid structure. Monitor whether there are any changes in patients' attention after treatment. |
| Rapid Serial Visual Presentation (RSVP) | Up to 2 weeks | Use programs to rapidly present image stimuli in order to assess patients' attention, recognition, or judgment abilities. |
Countries
China
Contacts
Primary ContactZhen W Wang, PhD，MD
Outcome results
None listed