Deep Brain Stimulation for Obsessive-Compulsive Disorder

Overseen By Abby Kiros

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must be taking: SSRIs, Clomipramine, Augmentation agents

Disqualifiers: Neurological disorder, Unstable medical illness, Psychosis, Substance abuse, others

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

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called deep brain stimulation (DBS) for individuals with severe obsessive-compulsive disorder (OCD) who haven't found relief from other methods. The researchers aim to enhance DBS effectiveness by customizing which brain connections in the anterior limb of the internal capsule (ALIC) are stimulated for each person, potentially improving treatment outcomes. Suitable candidates for this trial have had OCD for at least five years, haven't benefited from several medications and therapy sessions, and experience significant disruptions in daily life due to their OCD. As an unphased trial, this study offers an opportunity to contribute to innovative research that could lead to more personalized and effective OCD treatments.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, DBS is used as an additional treatment to medications, so you may be able to continue them. It's best to discuss this with the trial team.

What prior data suggests that this deep brain stimulation technique is safe for treating OCD?

Research has shown that deep brain stimulation (DBS) could benefit individuals with severe obsessive-compulsive disorder (OCD) who have not responded to other treatments. Studies indicate that about 60% of patients experience significant symptom improvement when DBS targets the anterior limb of the internal capsule (ALIC). Most patients tolerate DBS well, with mild and temporary side effects like headaches or dizziness. Serious complications are rare, making DBS a potentially safe option for those considering participation in a clinical trial for this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Connectomic Deep Brain Stimulation (DBS) is unique because it targets specific brain circuits believed to be involved in severe obsessive-compulsive disorder (OCD), unlike standard treatments like medication and cognitive behavioral therapy that have a more general effect. Researchers are excited because this precision approach could offer relief for patients who don't respond to existing therapies. By focusing on circuit-selective stimulation, this method has the potential to bring about significant improvements in symptoms with potentially fewer side effects.

What evidence suggests that connectomic deep brain stimulation is effective for obsessive-compulsive disorder?

Research shows that deep brain stimulation (DBS) can help people with severe obsessive-compulsive disorder (OCD) when other treatments have failed. In this trial, participants will receive Circuit-selective DBS, targeting a specific brain region called the anterior limb of the internal capsule (ALIC). Studies indicate that targeting this area significantly improves symptoms in about 60% of OCD patients. This treatment sends electrical signals to brain areas associated with OCD symptoms. By using advanced techniques to map brain connections, doctors aim to customize the treatment to fit each person's unique brain structure for optimal results. ^{1 2 4 6 7}

Who Is on the Research Team?

Ki Sueng Choi

Principal Investigator

Icahn School of Medicine and Mount Sinai

Martijn Figee

Principal Investigator

Icahn School of Medicine and Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults with severe OCD who haven't improved after trying multiple treatments, including at least three types of SSRIs, clomipramine, antipsychotic augmentation agents, and extensive CBT. They must score at least 25 on the Y-BOCS scale and be able to undergo MRI scans. Pregnant women or those with certain medical conditions or psychiatric diagnoses that increase risks are excluded.

Inclusion Criteria

I've tried antidepressants with specific additional medications without success.

I have had OCD for over 5 years and it significantly affects my daily life.

I can have an MRI before surgery.

Exclusion Criteria

Conditions requiring certain regular MRI scans or diathermy

Currently implanted with a cardiac pacemaker / defibrillator or other implanted electrical device which may interfere with DBS stimulator or the function of which may be impacted by its implantation, in the opinion of evaluating neurosurgeon

I cannot have general anesthesia, neurosurgery, or an MRI scan due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Planning

Patients receive a high definition 7T MRI brain scan to plan personalized lead implantation

1-2 weeks

1 visit (in-person)

Surgery and Initial Stimulation

Routine implantation of bilateral DBS leads into the ALIC brain region and initiation of stimulation

1 week

1 visit (in-person)

Postoperative Monitoring and Optimization

Routine clinical visits for optimizing DBS parameters and monitoring clinical effects

12 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Connectomic Deep Brain Stimulation

Trial Overview The study tests personalized deep brain stimulation (DBS) targeting the ALIC region in the brain for OCD patients. It aims to find specific neural pathways linked to individual symptoms and stimulate them precisely for better treatment outcomes.

How Is the Trial Designed?

Group I: Circuit-selective DBS Experimental Treatment 1 Intervention

People suffering from severe obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34482949/

Connectomic Deep Brain Stimulation for Obsessive ... - PubMed We propose a unified network that-when modulated by means of cortical or subcortical interventions-alleviates obsessive-compulsive symptoms.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05160129

NCT05160129 | Connectomic Deep Brain Stimulation for ... An effective DBS target for OCD is the anterior limb of the internal capsule (ALIC) brain region. On average 60% of all OCD patients have a clinically ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S000632232101461X

Connectomic Deep Brain Stimulation for Obsessive- ... In this critical review, we aim to scrutinize methodologies and findings from connectomic studies and DBS interventions for OCD to identify ...

4. nature.com nature.com/articles/s41467-020-16734-3

A unified connectomic target for deep brain stimulation in ... Our results show that connectivity-derived models may inform clinical improvements across DBS targets, surgeons and centers.

5. biologicalpsychiatryjournal.com biologicalpsychiatryjournal.com/cms/10.1016/j.biopsych.2021.07.010/attachment/895e3062-0087-49f1-a546-90afbd1b3761/mmc1.pdf

Connectomic Deep Brain Stimulation for Obsessive Stimulation through DBS electrodes modulates surrounding neural tissue as a function of the applied electric potential. The spatial extent of neural ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8474989/

Deep brain stimulation for obsessive-compulsive disorder The results confirm that deep brain stimulation (DBS) is a promising therapy for patients with severe and resistant forms of the disorder.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006322325010960

Deep Brain Stimulation Response Circuits in Obsessive- ... In DBS for obsessive-compulsive disorder (OCD), substantial progress has been made on both ends over the last 5 years. Together, the results ...