What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include pharmacotherapy with selective serotonin reuptake inhibitors (SSRIs) and cognitive-behavioral therapy (CBT). Side effects of SSRIs can include nausea, headache, and sexual dysfunction. CBT is generally well-tolerated but can cause temporary increases in anxiety. For treatment-resistant OCD, neuromodulation procedures like Deep Brain Stimulation (DBS) are considered. DBS involves electrical stimulation of specific brain regions and can lead to side effects such as infection, bleeding, and hardware complications. Additionally, patients may experience mood changes, headaches, and dizziness. Overall, while DBS can be effective for severe, treatment-resistant OCD, it carries significant risks that need to be carefully weighed.

What prior FDA approvals exist?

The FDA has approved several pharmacological treatments for Obsessive-Compulsive Disorder (OCD), including selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, sertraline, and paroxetine, as well as the tricyclic antidepressant clomipramine. For treatment-resistant OCD, neuromodulation techniques such as Deep Brain Stimulation (DBS) have been explored. DBS involves electrical stimulation of specific brain regions to modulate neural activity and has shown promise in severe, treatment-resistant cases. While DBS is not yet a standard FDA-approved treatment for OCD, it is considered a potential option for patients who do not respond to conventional therapies.

What other types of research exist?

Promising, novel alternatives to Deep Brain Stimulation (DBS) for OCD patients include Transcranial Direct Current Stimulation (tDCS) and Vagus Nerve Stimulation (VNS). tDCS involves stimulating the cortex with a weak electric current and has shown potential in improving symptoms in various neuropsychiatric conditions. VNS, which involves electrical stimulation of the vagus nerve, has shown benefits in treatment-resistant depression and may offer similar advantages for OCD.

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Procedure

DBS Therapy for Obsessive-Compulsive Disorder (DBS Trial)

N/A

Recruiting

Led By Albert J Fenoy, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

have failed to improve following treatment with at least 3 selective serotonin reuptake inhibitors (SSRIs)

meet established criteria for implantation of a deep brain stimulation system

Must not have

have had a previous surgery to destroy the region of the brain that will be the target of stimulation

have any neurological disorders, including dementia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the document doesn't specify side effects of Reclaim™ DBS Therapy directly, similar treatments may cause discomfort at implant site, headache, mood changes, movement issues or changes in thought processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried at least 3 SSRIs without improvement.

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I am eligible for a deep brain stimulation device implant.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have any neurological disorders, including dementia.

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I do not have a bleeding disorder and am not on blood thinners.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy as indicated by a decrease in obsessive compulsive symptoms as assessed by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

Secondary study objectives

Safety as indicated by the number of Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Reclaim™ DBS TherapyExperimental Treatment1 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).

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) include pharmacotherapy, cognitive-behavioral therapy (CBT), and Deep Brain Stimulation (DBS). Pharmacotherapy, primarily using selective serotonin reuptake inhibitors (SSRIs), increases serotonin levels in the brain to help reduce OCD symptoms. CBT, especially exposure and response prevention (ERP), helps patients confront their fears and reduce compulsive behaviors through structured exposure to anxiety-provoking stimuli. DBS involves electrical stimulation of specific brain regions, such as the anterior limb of the internal capsule, to modulate neural activity and alleviate severe, treatment-resistant OCD symptoms. Understanding these mechanisms is crucial for OCD patients as it highlights how different treatments can target various aspects of the disorder, offering hope for symptom relief and improved quality of life.

Deep brain stimulation for severe treatment-resistant obsessive-compulsive disorder: An open-label case series.