Treatment-refractory Obsessive-compulsive Disorder (trOCD)NCT07895706
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)
A study testing Radiosurgical anterior capsulotomy in people with Treatment-refractory Obsessive-compulsive Disorder (trOCD), run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment-refractory Obsessive-compulsive Disorder (trOCD)
- What is being tested?
- Radiosurgical anterior capsulotomy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Patient has prior ablative procedure to the brain (radiofrequency ablation, thermal ablation, laser interstitial thermal therapy, high-frequency ultrasound)
- Patient has MRI contraindications (cardiac implantable electronic devices, metallic intraocular foreign bodies, implantable neurostimulation systems, cochlear or ear implants, and drug infusion pumps)
- Pregnant women are excluded from this study.
- Patient has prior diagnosis of brain tumor
- Patient has active suicidal thoughts as assessed by a mental health professional
- Patient has comorbid neurodegenerative disorder
- Patient has history of substance use disorder in the past 24 months
- Patient deemed by study investigator to lack capacity to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
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.
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.
- Being tested
- Radiosurgical anterior capsulotomy
- Keywords
- Radiosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiosurgical anterior capsulotomyDevice
Radiotherapy will consist of stereotactic radiotherapy, delivered in a single or staged treatment to the bilateral anterior limb of the internal capsule. A maximum dose of 140Gy will be prescribed to a single isocenter on each side.
| Study group | Role | What they receive |
|---|---|---|
| Obsessive-compulsive disorder patients | Experimental | Patients with obsessive-compulsive disorder with severe symptoms that did not improve after several courses of medication and behavioral therapy. Receives: Device: Radiosurgical anterior capsulotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change is Yale-Brown Obsessive Compulsive Scale (Y-BOSC) score
Y-BOCS is a standardized form with a 58-item checklist to identify obsessions and compulsions and 10 questions to rate symptom severity, with lower scores indicating minimal or no symptoms.
Measured: Baseline, 3 months post treatment
Secondary outcomes (2)
Change in Y-BOCS score
Y-BOCS is a standardized form with a 58-item checklist to identify obsessions and compulsions and 10 questions to rate symptom severity, with lower scores indicating minimal or no symptoms.
Measured: Baseline, 6 months, 12 months post treatment
Number of adverse events as measured by medical record review
Measured: up to 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-refractory Obsessive-compulsive Disorder (trOCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haley Perlow, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895706
- Sponsor's protocol ID
- STUDY20251117
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07895706
- Acronym / sponsor ID
- STUDY20251117
- Keywords
- Radiosurgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obsessive-compulsive disorder patients | Experimental | Device: Radiosurgical anterior capsulotomyPatients with obsessive-compulsive disorder with severe symptoms that did not improve after several courses of medication and behavioral therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Patient has prior ablative procedure to the brain (radiofrequency ablation, thermal ablation, laser interstitial thermal therapy, high-frequency ultrasound)
- Patient has MRI contraindications (cardiac implantable electronic devices, metallic intraocular foreign bodies, implantable neurostimulation systems, cochlear or ear implants, and drug infusion pumps)
- Pregnant women are excluded from this study.
- Patient has prior diagnosis of brain tumor
- Patient has active suicidal thoughts as assessed by a mental health professional
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiosurgical anterior capsulotomyRadiotherapy will consist of stereotactic radiotherapy, delivered in a single or staged treatment to the bilateral anterior limb of the internal capsule. A maximum dose of 140Gy will be prescribed to a single isocenter on each side. | Device | Obsessive-compulsive disorder patients |
Primary outcome
Change is Yale-Brown Obsessive Compulsive Scale (Y-BOSC) score
Time frame: Baseline, 3 months post treatment
Y-BOCS is a standardized form with a 58-item checklist to identify obsessions and compulsions and 10 questions to rate symptom severity, with lower scores indicating minimal or no symptoms.
2 secondary outcomes
Change in Y-BOCS score
Time frame: Baseline, 6 months, 12 months post treatment
Number of adverse events as measured by medical record review
Time frame: up to 12 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiosurgical anterior capsulotomy in people with Treatment-refractory Obsessive-compulsive Disorder (trOCD), run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change is Yale-Brown Obsessive Compulsive Scale (Y-BOSC) score (time frame: Baseline, 3 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.