Deep Brain Stimulation for Obsessive-Compulsive Disorder

(OBSESS Trial)

Not yet recruiting at 1 trial location

Overseen By Sameer Sheth, PhD, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Non-rechargeable DBS generator

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to understanding and treating Obsessive-Compulsive Disorder (OCD) and bipolar disorder (BD) using deep brain stimulation (DBS). This technique sends electrical signals to specific brain areas. Researchers aim to gather detailed information on how individuals with these conditions behave in daily life, focusing on activities like socializing, moving around, and sleeping. Participants will wear devices such as smart rings and watches to track these behaviors in both a controlled apartment-like setting and at home. The trial is open to individuals already scheduled to receive DBS for their OCD or BD and who agree to participate in both study environments. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve future treatments for OCD and BD.

Will I have to stop taking my current medications?

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 deep brain stimulation is safe for treating OCD and BD?

Research has shown that deep brain stimulation (DBS) has been explored for treating various conditions, including obsessive-compulsive disorder (OCD). The Medtronic Percept RC neurostimulator is a device used in these treatments. In studies with Parkinson's Disease patients, DBS has generally been well-tolerated. However, the safety and benefits of this therapy for OCD remain under investigation.

DBS involves brain surgery, which carries risks such as serious complications like bleeding in the brain and seizures. Despite these potential risks, about two-thirds of patients with OCD have shown improvement after receiving DBS, experiencing at least a 25% reduction in their OCD symptoms over time.

While the FDA (U.S. Food and Drug Administration) has approved DBS for Parkinson's Disease, its use for OCD is still considered experimental. More research is needed to fully understand its safety and effectiveness for OCD patients. Prospective trial participants should consider these factors and discuss them with healthcare professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Deep brain stimulation (DBS) for Obsessive-Compulsive Disorder (OCD) is unique because it uses advanced technology to directly modulate brain activity. Unlike standard treatments like cognitive-behavioral therapy and medications, which can take time to see effects and might not work for everyone, DBS offers a more immediate and potentially transformative option. Researchers are particularly excited about the novel 16-contact leads from Boston Scientific, which provide more precise targeting in the brain, potentially leading to better outcomes for patients who haven't found relief with other treatments. This precision in targeting specific brain areas may help reduce OCD symptoms more effectively.

What evidence suggests that this trial's treatments could be effective for OCD?

Research has shown that deep brain stimulation (DBS) can effectively treat obsessive-compulsive disorder (OCD). About two-thirds of patients using DBS experienced a significant reduction in symptoms, with a 25% decrease in OCD severity after six months or more. Some patients even showed a 35% improvement in their obsessions and compulsions. This suggests that DBS can help many people manage their OCD symptoms. In this trial, researchers are studying the Medtronic Percept RC neurostimulator for this treatment. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 21-70 with severe OCD that hasn't improved after trying multiple treatments, including specific antipsychotics and SSRIs, clomipramine, and at least 20 sessions of cognitive-behavioral therapy. Participants must have a significant other to communicate with the research team if needed.

Inclusion Criteria

My depression, linked to my OCD, scores at least 16 on the HAM-D.

I have tried clomipramine without success.

I have had OCD for over 5 years that hasn't improved with treatment and significantly affects my daily life.

Exclusion Criteria

I do not have Tourette's with tics as severe as my OCD symptoms.

Pregnant or plans to become pregnant in the next 24 months

Any psychiatric disorder that, in the opinion of the Scientific Steering Group, may interfere with the candidate's ability to participate in study activities

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurobehavioral Unit (NBU) Assessment

Participants undergo reward-driven decision making tasks and sleep pattern assessments in a controlled environment

4-6 weeks

Multiple visits in the NBU

Home Environment Monitoring

Participants' behaviors are monitored in their natural home environment using wearables and peripherals

12 months

Follow-up

Participants are monitored for safety and effectiveness after the main study phases

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Commercially available 8-contact Boston Scientific leads
• Medtronic Percept RC neurostimulator
• Novel 16-contact Boston Scientific leads (total 64 implanted DBS contacts)

Trial Overview The OBSESS Trial is testing a Medtronic Percept RC neurostimulator device in patients with treatment-resistant OCD. It involves implanting DBS leads and temporary sEEG electrodes to personalize stimulation parameters aimed at reducing symptoms.

How Is the Trial Designed?

Group I: Medtronic Percept RC neurostimulator Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Brown University

Collaborator

Trials

480

Recruited

724,000+

Carnegie Mellon University

Collaborator

Trials

80

Recruited

540,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

William Marsh Rice University

Collaborator

Trials

50

Recruited

28,400+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Mclean Hospital

Collaborator

Trials

221

Recruited

22,500+

Published Research Related to This Trial

Deep brain stimulation (DBS) is an approved treatment for obsessive-compulsive disorder (OCD) but is still investigational for major depressive disorder (MDD), highlighting the need for more research to establish its efficacy for MDD.

Patients receiving DBS for OCD were generally younger and had different regional distributions compared to those with MDD, who were typically older and from higher-income families, indicating demographic differences that may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of patients who received deep brain stimulation in obsessive-compulsive disorder versus major depressive disorder. Youssef, NA., Phung, P., Patel, RS.[2021]

Deep brain stimulation (DBS) shows promise in treating severe cases of obsessive-compulsive disorder and major depression, particularly in patients who have not responded to other treatments, highlighting its potential efficacy in neuropsychiatric disorders.

The study emphasizes the need for ethical guidelines in the application of DBS for psychiatric conditions, focusing on principles like beneficence, nonmaleficence, and autonomy to ensure safe and responsible use in vulnerable patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrodes in the brain--ethical criteria for research and treatment with deep brain stimulation for neuropsychiatric disorders. Synofzik, M., Schlaepfer, TE.[2022]

Deep brain stimulation (DBS) for severe treatment-refractory obsessive-compulsive disorder (OCD) showed a significant long-term reduction in OCD symptoms by 39% over an average follow-up of 6.8 years, with half of the patients experiencing a substantial response.

DBS also led to significant improvements in anxiety and depression symptoms, quality of life, and overall functioning, while the unemployment rate decreased from 78% to 58%, indicating enhanced well-being despite some long-term adverse effects like cognitive complaints and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Outcome of Deep Brain Stimulation of the Ventral Part of the Anterior Limb of the Internal Capsule in a Cohort of 50 Patients With Treatment-Refractory Obsessive-Compulsive Disorder. Graat, I., Mocking, R., Figee, M., et al.[2021]

Deep brain stimulation (DBS) in the bed nucleus of stria terminalis (BNST) showed a significant response in 60% of the 10 patients with severe, treatment-resistant OCD, with an average symptom reduction of 53% as measured by the YBOCS scale.

The treatment not only reduced OCD symptoms but also improved depressive symptoms, global functioning, and quality of life, indicating that DBS could be a promising option for patients who do not respond to standard therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for treatment resistant obsessive compulsive disorder; an observational study with ten patients under real-life conditions. Abdelnaim, MA., Lang-Hambauer, V., Hebel, T., et al.[2023]

The Medtronic 'Percept' device, the first FDA-approved deep brain stimulation system with sensing capabilities, was tested on 7 subjects to identify and mitigate artifacts in local field potential signals that could affect its performance.

Using automated template subtraction techniques, researchers successfully removed various artifacts, such as ECG signals and nonphysiologic noise, which could otherwise distort the neural signals and impact the effectiveness of adaptive deep brain stimulation algorithms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. Hammer, LH., Kochanski, RB., Starr, PA., et al.[2023]

Citations

1. medtronic.com medtronic.com/en-us/healthcare-professionals/specialties/neurology/therapies-procedures/deep-brain-stimulation/conditions/obsessive-compulsive-disorder.html

Obsessive-Compulsive Disorder - Deep brain stimulation Learn about the results deep brain stimulation may provide to some patients who have obsessive-compulsive disorder.

2. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf

P960009/S478 Summary of Safety and Effectiveness (SSED) The study was a prospective, multicenter, single-arm, aDBS treatment mode blind, randomized crossover trial in subjects with Parkinson's Disease and DBS leads.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11485242/

Disruption of neural periodicity predicts clinical response after ... Disruption of neural periodicity predicts clinical response after deep brain stimulation for obsessive-compulsive disorder.

4. medtronic.com medtronic.com/se-sv/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation/clinical-outcomes/safety-probable-benefit-ocd.html

SAFETY and PROBABLE BENEFIT: OCD DEEP BRAIN ... Approximately two-thirds of the patients met the accepted criterion for a clinical response (25% reduction in YBOCS) at 6 months, 12 months, and last follow-up, ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37984432/

Clinical outcomes of deep brain stimulation for obsessive ... Results: Six participants achieved clinical response (35% improvement in obsessions and compulsions on the Yale Brown Obsessive Compulsive Scale (YBOCS)) within ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf5/H050003b.pdf

Summary of Safety and Probable Benefit - accessdata.fda.gov The ReclaimTM DBS Therapy for OCD uses implantable neurostimulators, extensions, and leads to deliver electrical stimulation to the anterior ...

7. medtronic.com medtronic.com/en-us/l/patients/treatments-therapies/deep-brain-stimulation-ocd/important-safety-information.html

Deep Brain Stimulation for Obsessive-Compulsive Disorder Placing the DBS system requires brain surgery, which can have serious and sometimes fatal complications including bleeding inside the brain, stroke, seizures, ...

8. medtronic.com medtronic.com/content/dam/medtronic-wide/public/united-states/products/neurological/dbs-percept-rc-media-kit.pdf

Introducing Percept™ RC neurostimulator with ... - Medtronic For Obsessive-Compulsive Disorder, the safety and probable benefit of this therapy has not been established for patients with: Tourette's syndrome, OCD with a ...