Ventral Capsulotomy for Obsessive-Compulsive Disorder

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Butler Hospital

Disqualifiers: Non-severe OCD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Ventral Capsulotomy for Obsessive-Compulsive Disorder?

A study on ventral capsular/ventral striatal gamma capsulotomy, a similar treatment, showed that 60% of patients with severe OCD experienced improvement 48 months after surgery, with only minor side effects. This suggests that ventral capsulotomy may also be effective for OCD. ^{1 2 3 4 5}

Is ventral capsulotomy safe for treating obsessive-compulsive disorder?

Ventral capsulotomy for obsessive-compulsive disorder has been studied and generally shows few adverse effects, with some cases reporting transient side effects. However, there are rare instances of complications, such as hallucinations, seizures, or behavior changes, and long-term effects like brain cysts can occur years after treatment. ^{1 4 6 7 8}

How is ventral capsulotomy different from other treatments for OCD?

Ventral capsulotomy is a unique treatment for OCD that involves a precise surgical procedure targeting specific brain areas, unlike conventional therapies like medication or cognitive-behavioral therapy. It is particularly used for patients who do not respond to standard treatments, offering a promising option with few adverse effects. ^{1 2 3 5 7}

Eligibility Criteria

This trial is for a small group of patients with severe Obsessive-Compulsive Disorder (OCD) who haven't improved after trying all other treatments. They must be approved by the Butler Hospital Psychiatric Neurosurgery Committee to undergo capsulotomy, a neurosurgical procedure.

Inclusion Criteria

I am approved for a specific brain surgery for severe OCD.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo capsulotomy, a neurosurgical procedure, to treat intractable OCD

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in brain structure and function, as well as clinical outcomes using neuroimaging and cognitive tasks

12 months

Multiple visits (in-person) for neuroimaging and assessments

Treatment Details

Interventions

• Ventral Capsulotomy

Trial Overview The study tests how making lesions in a specific brain area (anterior limb of the internal capsule) affects OCD symptoms. It uses imaging techniques and cognitive tasks to assess changes in brain structure and function after surgery.

Who Is Running the Clinical Trial?

Butler Hospital

Lead Sponsor

Trials

133

Recruited

16,700+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of resistant obsessive-compulsive disorder with ventral capsular/ventral striatal gamma capsulotomy: a pilot prospective study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Anterior Capsulotomy for Refractory Obsessive-Compulsive Disorder: A Tractography and Lesion Geometry study. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term follow-up of patients with obsessive-compulsive disorder treated by anterior capsulotomy: a neuropsychological study. [2010]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Bilateral anterior capsulotomy for refractory obsessive-compulsive disorders. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Lesion topography in capsulotomy for refractory anxiety--is the right side the right side? [2016]

6. England pubmed.ncbi.nlm.nih.gov

A register-based 13-year to 43-year follow-up of 70 patients with obsessive-compulsive disorder treated with capsulotomy. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Gamma Ventral Capsulotomy for Treatment-Resistant Obsessive-Compulsive Disorder: A Single-Center Experience. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Delayed Brain Cyst Formation After Gamma Knife Anterior Capsulotomy. [2021]