An interventional study of Radiosurgical anterior capsulotomy in Treatment-refractory Obsessive-compulsive Disorder (trOCD), sponsored by University Hospitals Cleveland Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by University Hospitals Cleveland Medical Center · Not applicable, Interventional, and Treatment
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.
University Hospitals Cleveland Medical Center is the lead sponsor of 294 studies on the registry; 44 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
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Exclusion Criteria:
Patients with obsessive-compulsive disorder with severe symptoms that did not improve after several courses of medication and behavioral therapy.
Device: Radiosurgical anterior capsulotomy
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.
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.
Time frame: Baseline, 3 months post treatment
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.
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
Change in behavioral symptoms as measured by the Hamilton Anxiety Rating Scale (HAM-A)
The Hamilton Anxiety Rating Scale (HAM-A) is a 14-item clinician-administered tool used to measure the severity of psychic (mental) and somatic (physical) anxiety. Each item is scored on a scale from 0 to 4, with 0: Not present, 1: Mild, 2: Moderate, 3: Severe, 4: Very severe.
Time frame: Baseline, 3 months, 6 months, 12 months
Change in behavioral symptoms as measured by the Quick Inventory of Depressive Symptomatology self-report (QIDS-SR)
The Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16) is a 16-item questionnaire that evaluates the severity of depressive symptoms over the past seven days. With lower scores indicating lower severity of depression.
Time frame: Baseline, 3 months, 6 months, 12 months
Change in behavioral symptoms as measured by the Clinical Global Impressions Scale (CIG)
The Clinical Global Impressions (CGI) scale is a clinician-rated tool used to measure psychiatric illness severity, global improvement, and treatment response. With lower scores indicating lower severity of illness or positive clinical improvement.
Time frame: Baseline, 3 months, 6 months, 12 months
Change in behavioral symptoms as measured by the Obsessive-Compulsive Inventory-Revised OCI-R
The Obsessive-Compulsive Inventory-Revised (OCI-R) is an 18-item self-report questionnaire to access the severity of obsessive-compulsive disorder (OCD). Scored on a Likert scale from 0 to 4, with 0 being not at all, and 4 being Extremely.
Time frame: Baseline, 3 months, 6 months, 12 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Feb 2029, 24 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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