DBS Therapy for Obsessive-Compulsive Disorder

(DBS Trial)

Recruiting at 1 trial location

Overseen By Samantha Gonzalez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Must be taking: SSRIs

Disqualifiers: Hoarding, Neurological disorders, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores Reclaim™ DBS Therapy to assist individuals with severe and persistent obsessive-compulsive disorder (OCD). The researchers aim to determine if this approach benefits those who haven't found relief from other treatments, such as medications or therapy. DBS (Deep Brain Stimulation) involves implanting a device that sends electrical signals to specific brain areas to reduce OCD symptoms. Individuals who have had OCD for at least five years, tried multiple medications without success, and do not have hoarding as their main issue might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially find relief from severe OCD symptoms.

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 prior data suggests that this DBS therapy is safe for treating OCD?

A previous study with 26 patients with severe OCD using Reclaim™ DBS Therapy showed promising outcomes. Deep Brain Stimulation (DBS) involves a surgical procedure where a device is placed in the brain to send electrical signals to specific areas. This method often treats severe OCD when medication and therapy prove ineffective.

Safety data from these studies indicate that DBS is generally well-tolerated. About two-thirds of patients experienced a 25% reduction in OCD symptoms, highlighting the treatment's potential benefits. However, like any medical procedure, there are risks. Some patients reported side effects such as headaches or infection at the implant site.

This treatment is considered for those who have not responded to other therapies, offering a reversible option compared to permanent brain surgeries. Overall, the data supports DBS as a viable and relatively safe option for severe OCD, though it should be carefully considered with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Reclaim™ DBS Therapy is unique because it takes a different approach by using deep brain stimulation (DBS) to directly target the brain regions involved in obsessive-compulsive disorder (OCD). Unlike traditional OCD treatments like cognitive-behavioral therapy (CBT) or medications such as selective serotonin reuptake inhibitors (SSRIs), which can take weeks or months to show effects, DBS offers a potentially faster and more direct intervention. Researchers are excited about this treatment because it involves a precise surgical technique to implant a neurostimulator in the brain, which could provide relief for patients who haven't responded to other therapies. This innovative method aims to manage OCD symptoms more effectively by altering the electrical activity in specific brain circuits.

What evidence suggests that Reclaim™ DBS Therapy is effective for OCD?

Research has shown that Deep Brain Stimulation (DBS), specifically the Reclaim™ DBS Therapy under study in this trial, can greatly benefit individuals with severe Obsessive-Compulsive Disorder (OCD) who haven't responded to other treatments. Studies indicate that, on average, patients experience a 40-45% reduction in symptoms. Approximately 60% of patients respond positively to the treatment. Many patients report significant improvements in their daily lives after receiving DBS. This therapy offers hope to those who haven't found success with medications or behavior therapy. ^{5 6 7 8 9}

Who Is on the Research Team?

Albert J Fenoy, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Reclaim™ DBS Therapy

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.

How Is the Trial Designed?

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).

Reclaim™ DBS Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Reclaim DBS Therapy for:

• Treatment-resistant obsessive-compulsive disorder (OCD)

Approved in European Union as Reclaim DBS Therapy for:

• Treatment-resistant obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

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

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]

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) 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) 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]

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) 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10533930/

Deep brain stimulation for treatment resistant obsessive ... Our results suggest that BNST-DBS can be effective for treatment-resistant OCD patients, as indicated by a reduction in symptoms and an overall improvement in ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0133591

Deep Brain Stimulation for Obsessive-Compulsive Disorder Global percentage of Y-BOCS reduction was estimated at 45.1% and global percentage of responders at 60.0%. Better response was associated with older age at OCD ...

3. nature.com nature.com/articles/s41380-019-0562-6

A prospective international multi-center study on safety and ... In conclusion, DBS for severe treatment-resistant OCD patients reduced the severity of obsessive-compulsive symptoms by an average of 40%, with ...

4. medschool.cuanschutz.edu medschool.cuanschutz.edu/psychiatry/PatientCare/obsessive-compulsive-disorder-program/reclaim-deep-brain-stimulation-therapy-for-ocd

Reclaim™ Deep Brain Stimulation (DBS) Therapy for ... One of the few centers in the US to offer Deep Brain Stimulation as an option for treatment-refractory obsessive-compulsive disorder.

5. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2020.00055/full

Deep Brain Stimulation for Obsessive–Compulsive Disorder The patient's YBOCS scores improved 32%, just failing to meet the threshold for treatment response. The patient subjectively reported improvement from the DBS ...

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 Find important safety information about deep brain stimulation therapy for obsessive-compulsive disorder.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7985042/

A prospective international multi-center study on safety and ... Recent systematic reviews and meta-analyses estimate reduction in OCD severity in response to DBS to be 45–48%. The global percentage of ...

9. 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, ...