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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with severe obsessive-compulsive disorder (OCD) when other treatments have failed. The treatment, ventral capsulotomy, involves a precise surgical procedure targeting specific brain areas associated with OCD. Researchers aim to determine how this surgery might alter brain structures and functions to reduce OCD symptoms. Suitable candidates for this trial are those with severe OCD unresponsive to standard therapies. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking OCD treatment.

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 prior data suggests that ventral capsulotomy is safe for treating obsessive-compulsive disorder?

Research has shown that ventral capsulotomy is generally well-tolerated by patients with severe OCD unresponsive to other treatments. Studies have found that the procedure does not affect patients' thinking and memory.

In one study, scores on the Yale-Brown Obsessive Compulsive Scale, which measures OCD symptoms, improved significantly over 36 months. This finding suggests the procedure is not only safe but also effective in reducing OCD symptoms over time.

While any surgery carries risks, ventral capsulotomy has been studied for several years. The absence of negative effects on thinking and memory, along with the improvement in OCD symptoms, makes it a promising option for those who haven't found relief with other treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for OCD?

Ventral capsulotomy is unique because it offers a surgical approach to treating obsessive-compulsive disorder (OCD) by targeting specific brain areas involved in the condition. Unlike standard treatments like medications and cognitive-behavioral therapy, which often require long-term commitment and may not work for everyone, ventral capsulotomy directly alters brain circuits thought to drive OCD symptoms. Researchers are excited about this treatment because it has the potential to provide relief for patients who haven't responded to other therapies, making it a promising option for those with severe, treatment-resistant OCD.

What evidence suggests that ventral capsulotomy might be an effective treatment for obsessive-compulsive disorder?

Research has shown that ventral capsulotomy can help people with severe OCD (obsessive-compulsive disorder) who do not respond to regular treatments. One study found that 63% of patients experienced significant symptom improvement after three years. Another study demonstrated that patients who received the treatment fared better than those who did not. On average, treatments like ventral capsulotomy, which target specific brain areas, have about a 55% success rate in reducing OCD symptoms. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29361268/

Gamma Ventral Capsulotomy in Intractable Obsessive- ... Gamma Knife ventral capsulotomy is an effective radiosurgical procedure for many treatment-refractory OCD patients.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25054836/

Gamma ventral capsulotomy for obsessive-compulsive ... Results: Three of 8 patients randomized to active treatment responded at 12 months, while none of the 8 sham-GVC patients responded (absolute risk reduction, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772529422000339

Network analysis in Gamma Knife capsulotomy for ... The mean total Y-BOCS reduction was 19.6 after three years, resulting in a response rate of 63%.The strongest correlation with symptom improvement was found for ...

4. frontiersin.org frontiersin.org/journals/integrative-neuroscience/articles/10.3389/fnint.2022.802617/full

The Patient Lived-Experience of Ventral Capsulotomy for ... To examine the lived experiences of patients who have undergone VC for severe, treatment-resistant OCD through qualitative analysis.

5. psychiatryinvestigation.org psychiatryinvestigation.org/m/journal/view.php?number=1661

Neuroablative Intervention for Refractory Obsessive- ... In another meta-analysis of the effectiveness of neuroablation treatment for OCD, the overall response rate for neuroablation treatment was 55% ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39187171/

Long-Term Safety and Efficacy of Focused Ultrasound ... Neuropsychological testing revealed no negative effects of capsulotomy. In the OCD and MDD cohorts, we found a correlation between clinical ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875020313565

Efficacy and Safety of Gamma Ventral Capsulotomy for ... The mean baseline Yale-Brown Obsessive Compulsive Scale score of 35.7 (n = 21) decreased to 15.3 (n = 20) at 36 months follow-up evaluation (P < 0.0001).