Cortical stimulation for treating obsessive-compulsive disorder
Adjunct Cortical Stimulation With Deep Brain Stimulation (DBS) to Treat Obsessive Compulsive Disorder (OCD)
NA · University of California, San Francisco · NCT04958096
This study is testing a new brain stimulation treatment for people with severe obsessive-compulsive disorder to see if it can help reduce their symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04958096 on ClinicalTrials.gov |
What this trial studies
This study aims to identify abnormal brain signals linked to obsessive-compulsive disorder (OCD) and explore new therapeutic stimulation sites in the brain. Patients with severe OCD will undergo deep brain stimulation (DBS) while their brain activity is monitored, specifically focusing on the anterior cingulate and prefrontal cortex. The study will be conducted in two phases: the first phase will involve long-term monitoring to identify biomarkers of OCD symptoms, while the second phase will introduce cortical stimulation to assess its impact on OCD symptoms. This innovative approach seeks to enhance the effectiveness of DBS by targeting specific brain regions associated with OCD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22-75 with a clinical diagnosis of severe OCD who have not responded to multiple standard treatments.
Not a fit: Patients with hoarding as a primary OCD subtype or those with other severe psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from severe OCD.
How similar studies have performed: While this approach is innovative, similar studies using deep brain stimulation for OCD have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to give informed consent for the study * Age 22-75 * Clinical diagnosis of OCD * Documented duration of OCD of at least 5 years * OCD rated as severe or extreme illness (YBOCs ≥ 28) * Has failed to improve following treatment with at least two selective serotonin reuptake inhibitors (SSRIs), clomipramine, and augmentation with antipsychotics * Has not responded to adequate trials of cognitive behavior therapy (exposure and response prevention) * Has not responded adequately to TMS treatment for OCD if it is reasonably available to the patient Exclusion Criteria: * Has hoarding as a primary subclassification of OCD according to DSM-4 * Has another severe psychiatric disorder (personality disorder, psychotic/bipolar disorder, etc) or substance abuse issues * Is pregnant * Has an abnormal MRI assessed by the team or has a neurological condition requiring an MRI in the future * Has a cognitive disorder or dementia * Is at imminent risk for suicide based upon Suicide Severity Rating Scale (SSRS) or has ever attempted suicide * Inability to comply with study follow-up visits * Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin) * Allergies or known hypersensitivity to materials in the Activa systems (i.e. titanium, polyurethane, silicone, polyethermide, stainless steel). * Previous cranial ablative or deep brain stimulation surgery. * Patients may be excluded from enrollment due to a condition that, in the judgement of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS.
Where this trial is running
San Francisco, California
- UCSF Nancy Friend Pritzker Psychiatry Building — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Andrew M Lee, MD, PhD — University of California, San Francisco
- Study coordinator: Andrew M Lee, MD, PhD
- Email: ocdresearch@ucsf.edu
- Phone: 415-502-5472
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.
Conditions: Obsessive-Compulsive Disorder, OCD, Obsessive Compulsive Disorder, Obsessive thoughts, Compulsions