Ventral Capsulotomy for Intractable OCD

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Cognition and Magnetic Resonance Imaging After Psychiatric Neurosurgery for Intractable Obsessive-Compulsive Disorder- Phase 2

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05659082
• Other study ID #: 1909-001
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: June 21, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: January 2023
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Obsessive-compulsive disorder (OCD) is a common condition. One to two percent of the population experiences the chronic intrusive obsessive thoughts, repetitive compulsions, and pathological anxiety characteristic of the illness, which by several measures is among the ten most disabling medical conditions for adults in industrialized countries. 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. OCD is believed to result from abnormal activity in brain circuits connecting the prefrontal cortex, thalamus and other brain areas. Data show that approximately 50 to 60 percent of patients improve after capsulotomy.

In addition, new neuroimaging measures of how brain fiber tracts and the brain regions associated with them change after capsulotomy promise to enhance the understanding of OCD pathophysiology, and may help advance capsulotomy and other neuroanatomically-based therapies. While capsulotomy is believed to exert its therapeutics effects by changing thalamus-prefrontal cortex connections, the specific anatomical changes produced by this surgical treatment in these fiber pathways are unknown. This is especially true at greater distances from the site of surgery, that is, closer to the thalamus and prefrontal cortex, the regions the surgery is intended to partially disconnect from each other. 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. Additional measures of how brain volumes may change in specific corticobasal structures implicated in OCD (including the basal ganglia, thalamus, and orbitofrontal cortex) will be derived from conventional MRI measures obtained during the same sessions when the experimental DT-MRI measures are acquired. The investigators will also utilize experimental cognitive tasks that are sensitive to the circuitry impacted by this procedure.

Understanding the changes after surgery that result in the best therapeutic outcomes will allow the investigators to improve capsulotomy as a treatment for this debilitating disease. With this information, the investigators can refine the targeting of capsulotomy for individual patients and, possibly, aid the development of other treatments, including deep brain stimulation, for intractable OCD. This study provides a unique opportunity to test structural and functional connectivity measures as probes of complex neuronal circuits that are likely to be involved in psychiatric illness.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients who will be undergoing capsulotomy for severe OCD, as approved by the Butler Hospital Psychiatric Neurosurgery Committee

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• Laser Interstitial Thermal Therapy
Ventral capsulotomy for OCD using laser interstitial thermal therapy

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Hamilton Depression Rating Scale (HDRS)	Change from baseline to 12 months on HDRS score; HRDS scores range from 0-52, with higher scores indicating more severe illness	12 months
Secondary	Hamilton Anxiety Rating Scale (HARS)	Change from baseline to 12 months on HARS score; HARS score ranges from 0-56, with higher scores indicating more severe illness	12 months