The Efficacy of Temporal Interference Stimulation in the Treatment of Obsessive-Compulsive Disorder
Recruiting · NCT07113652 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Mental Health Center
View the official record on ClinicalTrials.gov →Interventions studied
TI stimulation device (nerviox-1000）
What this trial is about
This study aims to evaluate the efficacy of Temporal Interference (TI) stimulation in treating patients with obsessive-compulsive disorder (OCD) and to explore its potential neural mechanisms using magnetic resonance imaging (MRI) and electroencephalography (EEG).
Who can take part
Age range
18 Years to 50 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 18-50 years old
- Diagnosis of OCD per DSM-5
- Y-BOCS score ≥20
- Have a documented history of at least two adequate trials of selective serotonin reuptake inhibitors (SSRIs). If currently receiving SSRI treatment, the dosage must be stable for at least 8 weeks prior to enrollment
- With at least 9 years of education
Exclusion criteria
- Any DSM-5 diagnosis other than OCD (except OCPD)
- OCD symptoms too severe to complete assessments
- Received electroconvulsive therapy (ECT) within the past 6 months
- Received other forms of neuromodulation within the past 2 months（see Item 3 for ECT）
- Severe medical illness or seizure risk (e.g., cardiovascular, respiratory conditions)
- Neurological disorders or history of brain injury/surgery
- MRI-incompatible implants (e.g., pacemaker, stents, cochlear implants).
- Current suicidal risk per investigator judgment
- Pregnant or planning pregnancy during the study
- Started structured OCD psychotherapy within 3 months, with expected change during treatment
Where it is running
1 location listed.
- Shanghai Mental Health Center - Shanghai, Shanghai Municipality, China