Ventral Capsulotomy for Intractable OCD
Cognition and Magnetic Resonance Imaging After Psychiatric Neurosurgery for Intractable Obsessive-Compulsive Disorder- Phase 2
1 other identifier
interventional
50
1 country
1
Brief Summary
Obsessive-compulsive disorder impacts 1-2 percent of the population. Unfortunately, about fifteen percent of patients fail to benefit from existing therapies. A small number of OCD patients, who have a disabling illness that does not improve after conventional treatments, have neurosurgery as a last resort. One procedure, capsulotomy, involves making pairs of lesions in an anatomically-defined part of the anterior limb of the internal capsule, a structure containing nerve fiber bundles connecting the thalamus, in the center of the brain, to the prefrontal cortex, the most anterior and outermost brain region. The investigators will examine how the therapeutic effects of capsulotomy relate to changes in the structure of these brain pathways with structural (diffusion tensor imaging, DTI) and functional (resting-state and task-based) connectivity metrics. The investigators will also utilize experimental cognitive tasks that are sensitive to the circuitry impacted by this procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2022
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 21, 2022
CompletedFirst Submitted
Initial submission to the registry
December 5, 2022
CompletedFirst Posted
Study publicly available on registry
December 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2032
January 26, 2023
January 1, 2023
10.5 years
December 5, 2022
January 25, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Change from baseline to 12 months on YBOCS score; YBOCS score ranges from 0-40, and higher scores indicate more severe illness
12 months
Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Change from baseline to 24 months on YBOCS score; YBOCS score ranges from 0-40, and higher scores indicate more severe illness
24 months
Secondary Outcomes (2)
Hamilton Depression Rating Scale (HDRS)
12 months
Hamilton Anxiety Rating Scale (HARS)
12 months
Interventions
Ventral capsulotomy for OCD using laser interstitial thermal therapy
Eligibility Criteria
You may qualify if:
- Patients who will be undergoing capsulotomy for severe OCD, as approved by the Butler Hospital Psychiatric Neurosurgery Committee
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Butler Hospital
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Psychologist, Associate Professor
Study Record Dates
First Submitted
December 5, 2022
First Posted
December 21, 2022
Study Start
June 21, 2022
Primary Completion (Estimated)
December 31, 2032
Study Completion (Estimated)
December 31, 2032
Last Updated
January 26, 2023
Record last verified: 2023-01