Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Key facts
- Who runs it
- University Hospitals Cleveland Medical Center
- Where
- Cleveland, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 10 people, planned
- Starts
- 1 Feb 2027
- Expected to end
- 1 Feb 2029
- Type of study
- Interventional
- Treatments tested
- Radiosurgical anterior capsulotomy
- Record updated
- 26 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- Age 18 or older at time of enrollment
- Documented diagnosis of Obsessive Compulsive Disorder (OCD)
- Y-BOCS score of 28 or higher confirmed with behavioral testing during pre-existing clinical documentation
- Two trials of selective serotonin reuptake inhibitors for an adequate duration at maximally tolerated dose OR one trial of a selective serotonin reuptake inhibitor with antipsychotic augmentation for an adequate duration at maximally tolerated dose OR one trial of a selective serotonin reuptake inhibitor and clomipramine for an adequate duration at maximally tolerated dose
- Nonresponse to at least one trial of Exposure-Response Prevention behavioral therapy for an adequate duration
- Patient able to understand written and spoken English
Who cannot take part
- Patient has prior ablative procedure to the brain (radiofrequency ablation, thermal ablation, laser interstitial thermal therapy, high-frequency ultrasound)
- Patient has prior diagnosis of brain tumor
- Patient has MRI contraindications (cardiac implantable electronic devices, metallic intraocular foreign bodies, implantable neurostimulation systems, cochlear or ear implants, and drug infusion pumps)
- Patient has comorbid neurodegenerative disorder
- Patient has history of substance use disorder in the past 24 months
- Pregnant women are excluded from this study
- Patient has active suicidal thoughts as assessed by a mental health professional
- Patient deemed by study investigator to lack capacity to provide informed consent
Where in United States
- University Hospitals Cleveland Medical Center*Cleveland, United StatesNot yet recruiting
About the trial
What the trial wants to find out
One treatment for treatment-refractory OCD is a procedure called anterior capsulotomy, which modifies a part of the brain called the anterior limb of the internal capsule (ALIC). The ALIC contains connections between some regions of the brain that are overactive in OCD. Anterior capsulotomy can be done with a minimally invasive procedure called radiosurgery, which uses a one-time targeted radiation treatment to weaken the hyperactive connections that travel through the ALIC.
Read full original descriptionShow less
Traditionally, radiosurgery was done using a machine called the Gamma Knife. Many radiation treatment centers use a different type of treatment machine, called a linear accelerator, to treat conditions in the brain that were traditionally treated on the Gamma Knife.
This study will enroll 10 patients and offer anterior capsulotomy on a linear accelerator radiosurgery system and monitor participants OCD symptom improvement after the procedure. This study will also use a special type of brain imaging technique, called task-based functional MRI, to collect information about brain activity before and after treatment.
The group in the trial
- Obsessive-compulsive disorder patientsTreatment being tested
Patients with obsessive-compulsive disorder with severe symptoms that did not improve after several courses of medication and behavioral therapy.
Treatment: Radiosurgical anterior capsulotomy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 26 October 2026