DBS Therapy for Obsessive-Compulsive Disorder

(DBS Trial)

Recruiting at 1 trial location

Overseen by Albert J Fenoy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwell Health

Must be taking: SSRIs

Disqualifiers: Hoarding, Neurological disorders, Pregnancy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial involves using Deep Brain Stimulation (DBS) to help patients with severe OCD who haven't responded to other treatments. The DBS device sends electrical signals to specific brain areas to control OCD symptoms by regulating abnormal brain activity.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since it mentions that participants must have failed to improve with at least 3 SSRIs, it seems likely that continuing current medications might be allowed.

What data supports the effectiveness of the treatment Reclaim™ DBS Therapy for Obsessive-Compulsive Disorder?

Deep brain stimulation (DBS) has been shown to reduce symptoms and improve overall functioning in patients with severe OCD who do not respond to other treatments. It has been used successfully for other conditions like Parkinson's disease, and its application to OCD has received approval from the FDA due to promising results. ^{1 2 3 4 5}

Is DBS therapy safe for treating obsessive-compulsive disorder?

Deep brain stimulation (DBS) for obsessive-compulsive disorder (OCD) has been studied for safety, with most adverse events being mild or moderate and often related to the programming of the device. Serious adverse events can occur, but they are less common and usually resolve with adjustments to the stimulation settings. ^{3 6 7 8 9}

How is DBS Therapy different from other treatments for OCD?

DBS Therapy for OCD is unique because it involves implanting electrodes in specific brain areas to directly change brain activity, unlike traditional treatments like therapy or medication. This approach is particularly used for severe cases where other treatments have not worked. ^{2 3 4 5 8}

Research Team

Albert J Fenoy, MD

Principal Investigator

Northwell Health

Eligibility Criteria

This trial is for adults over 18 with severe or extreme OCD lasting at least 5 years, who haven't responded to CBT and at least three SSRIs. Candidates should not have primary hoarding symptoms, previous brain surgery in the target area, neurological disorders like dementia, be pregnant, have bleeding disorders or need routine MRIs.

Inclusion Criteria

You have severe or extreme OCD.

You have both depression and anxiety at the same time.

I have completed or attempted Cognitive Behavior Therapy.

Exclusion Criteria

You have a condition of hoarding as your main problem.

I've had surgery before on the part of my brain that will be stimulated.

I do not have any neurological disorders, including dementia.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgery

DBS lead is stereotactically introduced into the brain and connected to a neurostimulator

1 day

1 visit (in-person)

Post-Surgery Follow-up

Participants are monitored for clinical effect and side effects after surgery

6 months

Visits at 2 weeks, 1, 2, 3, 4, 6 months

Long-term Follow-up

Participants are monitored every 6 months for ongoing safety and effectiveness

1 year

Every 6 months

Treatment Details

Interventions

• Reclaim™ DBS Therapy (Procedure)

Trial Overview The Reclaim™ DBS Therapy is being tested as an alternative to irreversible neurosurgical procedures for patients with chronic, severe OCD resistant to medication and behavioral therapy. It involves stimulating specific brain regions without destroying tissue.

Participant Groups

Group I: Reclaim™ DBS Therapy Experimental Treatment 1 Intervention

Procedure: The DBS lead is stereotactically introduced into the target in the brain and fixed to the skull; the lead is then connected to a neurostimulator implanted subcutaneously in the subclavicular region. This is performed by a neurosurgeon skilled in this technique, as the same procedure is routinely performed in patients with other diseases (using other brain targets).

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Michael Dowling

Northwell Health

Chief Executive Officer since 2002

Bachelor's and Master's degrees from University College Cork, Ireland

Dr. David Battinelli

Northwell Health

Chief Medical Officer since 2022

MD from Georgetown University School of Medicine

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Dr. LaTanya Love

The University of Texas Health Science Center, Houston

Interim President

MD from UT Medical Branch in Galveston

Dr. Jagat Narula

The University of Texas Health Science Center, Houston

Chief Academic Officer since 2023

MD, PhD

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

Deep brain stimulation (DBS) targeting the internal capsule (IC) significantly reduced excessive grooming behaviors in Sapap3 mutant mice, a model for obsessive-compulsive disorder (OCD), indicating its potential efficacy in treating OCD symptoms.

While both IC and dorsal part of the ventral striatum (dVS) stimulation modulated prefrontal cortical activity, IC-DBS was more effective and also increased locomotion, suggesting a need to balance therapeutic effects with potential side effects in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential Effects of Deep Brain Stimulation of the Internal Capsule and the Striatum on Excessive Grooming in Sapap3 Mutant Mice. Pinhal, CM., van den Boom, BJG., Santana-Kragelund, F., et al.[2019]

In a study of 52 patients with refractory OCD who underwent deep brain stimulation (DBS), those who received cognitive behavioral therapy (CBT) showed a modest reduction in obsessive-compulsive symptoms, with a 14.8% decrease in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) scores after an average of 10.4 months of CBT.

However, when comparing matched groups of patients with and without CBT, both groups experienced similar reductions in Y-BOCS scores, suggesting that the improvements may be primarily due to the effects of DBS itself rather than the addition of CBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy in patients with deep brain stimulation for obsessive-compulsive disorder: a matched controlled study. Graat, I., Franken, S., van Rooijen, G., et al.[2023]

Deep brain stimulation (DBS) has been effectively used for treating severe, refractory obsessive-compulsive disorder (OCD), building on decades of experience with neurosurgical interventions.

The therapy received Humanitarian Device Exemption (HDE) approval from the FDA in 2009 due to promising results, indicating its potential as a viable treatment option for patients with OCD who do not respond to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for obsessive-compulsive disorder. Arya, S., Filkowski, MM., Nanda, P., et al.[2019]

Deep brain stimulation (DBS) is a novel treatment for severe obsessive-compulsive disorder (OCD) that directly modulates brain activity, offering a different mechanism of action compared to traditional therapies like medication and psychotherapy.

The effectiveness of DBS is evaluated through an interactive process between clinicians and patients, where improvements are seen as increased patient engagement and openness to therapeutic activities, suggesting that DBS can enhance the potential for additional cognitive behavioral therapy (CBT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Deep Brain Stimulation for Obsessive-Compulsive Disorder Requires Clinical Expertise. van Westen, M., Rietveld, E., Denys, D.[2023]

Deep brain stimulation (DBS) of the subthalamic nucleus can significantly reduce the severity of symptoms in patients with severe and persistent Obsessive Compulsive Disorder (OCD), especially in those who do not respond to traditional treatments.

DBS not only helps alleviate OCD symptoms but also enhances overall functioning, providing insights into the underlying mechanisms of the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[OCD: when limbic systems start looping...]. Flores Alves dos Santos, J., Mallet, L.[2013]

In a study of 30 patients with severe, treatment-refractory OCD, deep brain stimulation (DBS) showed a 42% reduction in obsessive-compulsive symptoms after 12 months, with a responder rate of 60%.

While all patients experienced adverse events (195 total), most were mild or moderate, and the serious adverse events were primarily transient anxiety and worsening of affective symptoms, suggesting that the benefits of DBS may outweigh the risks in this challenging patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder. Menchón, JM., Real, E., Alonso, P., et al.[2022]

Deep brain stimulation (DBS) for treatment-resistant obsessive-compulsive disorder (OCD) has been associated with various adverse events, with psychiatric issues being the most common (40%), followed by neurological problems (19%) and infections (10%).

The study highlights that while DBS may be a viable treatment option for certain patients with refractory OCD, ongoing monitoring and further research are necessary to fully understand the long-term safety and efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for refractory obsessive-compulsive disorder: A review and analysis of the FDA MAUDE database. Porwal, MH., Karra, H., Sharma, U., et al.[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) is an effective treatment for patients with therapy-refractory obsessive-compulsive disorder (OCD), with insights gained from treating over 80 patients since 2005, making it the largest cohort studied.

Optimizing DBS parameters requires careful adjustment of stimulation settings, considering the timing of symptom changes and potential side effects, as well as the patient's ability to engage in additional cognitive-behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Deep Brain Stimulation Parameters in Obsessive-Compulsive Disorder. van Westen, M., Rietveld, E., Bergfeld, IO., et al.[2023]

References

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

Differential Effects of Deep Brain Stimulation of the Internal Capsule and the Striatum on Excessive Grooming in Sapap3 Mutant Mice. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy in patients with deep brain stimulation for obsessive-compulsive disorder: a matched controlled study. [2023]

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

Deep brain stimulation for obsessive-compulsive disorder. [2019]

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

Effective Deep Brain Stimulation for Obsessive-Compulsive Disorder Requires Clinical Expertise. [2023]

5. France pubmed.ncbi.nlm.nih.gov

[OCD: when limbic systems start looping...]. [2013]

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

A prospective international multi-center study on safety and efficacy of deep brain stimulation for resistant obsessive-compulsive disorder. [2022]

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

Deep brain stimulation for refractory obsessive-compulsive disorder: A review and analysis of the FDA MAUDE database. [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

Optimizing Deep Brain Stimulation Parameters in Obsessive-Compulsive Disorder. [2023]