Deep Brain Stimulation for Obsessive-Compulsive Disorder

(OBSESS Trial)

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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests deep brain stimulation (DBS) for patients with severe OCD who haven't improved with other treatments. DBS involves placing electrodes in the brain to send electrical signals to specific areas. The study aims to personalize these signals using advanced technology to improve treatment outcomes and make the therapy more accessible.

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 data supports the effectiveness of this treatment for obsessive-compulsive disorder?

Deep brain stimulation (DBS) has been shown to be an effective treatment for severe cases of obsessive-compulsive disorder (OCD) that do not respond to other therapies. It has been used successfully in movement disorders and is now applied to psychiatric conditions like OCD, with studies indicating improvements in symptoms and quality of life for patients. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) has been used safely for almost 50 years in treating various conditions, including movement disorders and psychiatric conditions like obsessive-compulsive disorder (OCD) and depression. While generally well tolerated, some specific side effects have been observed, such as mood changes, which vary depending on the target area in the brain being stimulated. ^{3 6 7 8 9}

How is deep brain stimulation different from other treatments for obsessive-compulsive disorder?

Deep brain stimulation (DBS) is a unique treatment for obsessive-compulsive disorder (OCD) because it involves implanting electrodes in specific brain areas to modulate brain activity, which is different from medications or therapy that work through chemical or behavioral changes. This approach is particularly used for patients who do not respond to standard treatments, offering a new option for those with severe, treatment-resistant OCD. ^{2 3 4 8 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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) 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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Perspectives of Implementation of Closed-Loop Deep Brain Stimulation: From Neurological to Psychiatric Disorders. [2023]

2. Italy pubmed.ncbi.nlm.nih.gov

Deep-brain stimulation of the nucleus accumbens in obsessive compulsive disorder: clinical, surgical and electrophysiological considerations in two consecutive patients. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation for addiction, anorexia and compulsion. Rationale, clinical results and ethical implications]. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for treatment-refractory obsessive compulsive disorder: a systematic review. [2023]

5. United States 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. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. [2023]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Characteristics of patients who received deep brain stimulation in obsessive-compulsive disorder versus major depressive disorder. [2021]

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

Deep brain stimulation for intractable psychiatric disorders. [2012]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for treatment resistant obsessive compulsive disorder; an observational study with ten patients under real-life conditions. [2023]