What side effects are associated with this type of intervention?

The most common treatments for Obsessive-Compulsive Disorder (OCD) include neuromodulation techniques such as Deep Brain Stimulation (DBS), Transcranial Magnetic Stimulation (TMS), and Transcranial Direct Current Stimulation (tDCS). DBS can cause side effects like impulsivity, sleeping problems, tension, and in rare cases, generalized tonic-clonic seizures. TMS may lead to headaches, scalp discomfort, and a small risk of seizures. tDCS is generally well-tolerated but can cause mild skin irritation and tingling at the electrode sites. These treatments are typically considered when traditional therapies are ineffective.

What prior FDA approvals exist?

The FDA has approved several treatments for Obsessive-Compulsive Disorder (OCD), primarily focusing on pharmacological options such as selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, sertraline, and paroxetine, as well as the tricyclic antidepressant clomipramine. For treatment-resistant OCD, the FDA has approved deep brain stimulation (DBS) as a Humanitarian Device Exemption (HDE), which allows its use under specific conditions due to its potential benefits despite limited evidence from large-scale trials. DBS involves the implantation of electrodes in specific brain regions to modulate neural activity and has shown promise in reducing OCD symptoms in patients who do not respond to conventional treatments.

What other types of research exist?

Promising novel alternatives to Deep Brain Stimulation for OCD include Transcranial Direct Current Stimulation (tDCS) and Transcranial Magnetic Stimulation (TMS). tDCS involves using a weak electric current to stimulate the cortex and has shown potential in improving symptoms in various neurological conditions. TMS, particularly repetitive TMS (rTMS), has been explored for its efficacy in reducing symptoms of OCD and other psychiatric disorders.

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Device

Deep Brain Stimulation for Obsessive-Compulsive Disorder

N/A

Recruiting

Research Sponsored by Casey H. Halpern, M.D.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 4 years

Summary

This trial tests a device that sends electrical signals to the brain in patients with severe OCD who don't respond to usual treatments. The electrical pulses aim to help control OCD symptoms. This experimental treatment has shown promising results for severe OCD.

Who is the study for?

This trial is for adults aged 22-65 with severe, treatment-resistant Obsessive-Compulsive Disorder (OCD), having tried multiple medications and cognitive therapy without success. Participants must be able to follow the study's procedures in English, live within a 6-hour drive of the study sites, have stable housing and support, and commit to no psychotherapy or medication changes during the trial.

What is being tested?

The trial tests SEEG-guided Deep Brain Stimulation (DBS) using Vercise Genus™ System on those with severe OCD. It involves brain mapping, DBS surgery, parameter optimization, randomized crossover treatment phases followed by open label stimulation over approximately an 18-month period.

What are the potential side effects?

Potential side effects may include discomfort at implantation sites, headache or dizziness post-surgery; risk of infection; possible changes in mood or behavior; unintended movements; speech disturbances; sensory issues like tingling or numbness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Primary Efficacy Endpoint - Treatment Response

Primary Feasibility Endpoint #1 - OCD Relevant Network

Primary Feasibility Endpoint #2 - Stimulation Target That Acutely Improves OCD Symptoms

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SEEG Guided DBS ON-OFF (Stimulation-Sham)Experimental Treatment2 Interventions

Patients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period.

Group II: SEEG Guided DBS OFF-ON (Sham-Stimulation)Placebo Group2 Interventions

Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point.

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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 Cognitive-Behavioral Therapy (CBT), pharmacotherapy, and neuromodulation techniques like Deep Brain Stimulation (DBS). CBT works by exposing patients to their fears and preventing their usual compulsive responses, thereby reducing anxiety over time. Pharmacotherapy typically involves selective serotonin reuptake inhibitors (SSRIs) that help balance neurotransmitters in the brain. DBS, a more advanced treatment for severe, treatment-resistant OCD, involves implanting electrodes in specific brain regions to modulate neural activity. This electrical stimulation can help normalize the dysfunctional brain circuits associated with OCD, offering relief when other treatments have failed. Understanding these mechanisms is crucial for tailoring effective treatment plans and improving patient outcomes.

Deep brain stimulation for severe treatment-resistant obsessive-compulsive disorder: An open-label case series.Brain stimulation techniques in the treatment of obsessive-compulsive disorder: current and future directions.