Non-invasive treatment for OCD using neuromodulation
Neuromodulation for a Novel OCD Biomarker and Treatment
This study is testing a new non-invasive brain treatment to see if it can help people with OCD who haven't found relief from other therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Charles River Campus Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05994053 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a new non-invasive neuromodulation technique to reduce symptoms of obsessive-compulsive disorder (OCD). The approach utilizes high-definition transcranial alternating current stimulation (HD-tACS) guided by EEG recordings to target the orbitofrontal cortex, a brain region implicated in OCD. The study will focus on patients with a primary diagnosis of OCD who have not responded adequately to existing treatments. Preliminary data suggest that this method may lead to rapid and sustained reductions in OCD symptoms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a primary diagnosis of OCD and a YBOCS score of 16 or greater.
Not a fit: Patients with a history of bipolar or psychotic disorders, severe depression, or those currently undergoing significant changes in pharmacotherapy for OCD may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and tolerable option for patients suffering from OCD.
How similar studies have performed: Preliminary data from similar approaches have shown promising results, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: (1) a primary DSM-5 diagnosis of OCD, (2) a score of 16 or greater on the YBOCS (3) at least 18 years of age; and (4) willingness and ability to provide informed consent and comply with the requirements of the study protocol. Exclusion Criteria: (1) a lifetime history of bipolar or psychotic disorders; (2) history of Tourette syndrome; (3) psychosurgery; (4) substance abuse or dependence (other than nicotine) in the past 3 months; (5) organic brain syndrome, mental retardation or other potentially interfering cognitive dysfunction; (6) severe depression (MADRS score of 30 or greater); (7) suicidal risk as determined by moderate or greater score on the Columbia Suicide Severity Rating Scale (C-SSRS); (8) pregnancy or lactation; (9) changes to pharmacotherapy for OCD or the initiation of cognitive-behavior therapy within the last 3 months; and (10) specific to the tACS and EEG procedures no metal implants in head, any implanted electronic devices, any skin sensitivity, color blindness or impaired vision despite correction, claustrophobia, and any history of epilepsy or neurological disorder.
Where this trial is running
Boston, Massachusetts
- Boston University Center for Anxiety and Related Disorders (BU-CARD) — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Robert Reinhart, PhD
- Email: rmgr@bu.edu
- Phone: 6173539481
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.