Temporal interference stimulation for obsessive-compulsive disorder
Exploring the Efficacy of Temporal Interference Stimulation in the Treatment of Obsessive-Compulsive Disorder
This project will try noninvasive temporal interference brain stimulation in adults with moderate-to-severe OCD to see if stimulating different deep brain targets reduces symptoms compared with sham.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Shanghai Mental Health Center Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07113652 on ClinicalTrials.gov |
What this trial studies
This is a randomized, blinded, multi-phase trial testing temporal interference (TI) stimulation in adults with treatment-resistant OCD and comparing stimulation of different deep brain targets. In Phase 1 participants are randomized to sham, bilateral nucleus accumbens (NAcc) stimulation, or bilateral bed nucleus of the stria terminalis (BNST) stimulation. Non-responders move to Phase 2 to receive stimulation of the opposite target (with sham participants re-randomized), and Phase 3 offers exploratory targeting of the caudate, putamen, or amygdala for remaining non-responders. Treatment is delivered twice daily for 7 days per phase with pre- and post-phase MRI, EEG, symptom scales, cognitive testing, and follow-up assessments for up to 4 weeks.
Who should consider this trial
Good fit: Adults 18–50 years old with DSM-5 OCD, Y-BOCS score ≥20, at least two adequate SSRI trials (and stable SSRI dose ≥8 weeks if currently treated), and at least 9 years of education are the intended participants.
Not a fit: Patients with other current DSM-5 diagnoses (except OCPD), recent ECT or neuromodulation, significant neurological or medical illness, MRI-incompatible implants, current suicidal risk, pregnancy, or OCD too severe to complete assessments are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, TI could provide a noninvasive, targeted brain-stimulation option to reduce OCD symptoms for patients who have not responded to medications.
How similar studies have performed: Temporal interference as a human therapeutic approach is novel with very limited clinical data, while related methods such as deep brain stimulation and TMS have helped some patients but are not universally effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai Mental Health Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhen Wang, PhD,MD
- Email: wangzhen@smhc.org.cn
- Phone: +86 34773516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.