What is the mechanism of action of this treatment?

The most common treatments for Obsessive-Compulsive Disorder (OCD) include pharmacological approaches like selective serotonin reuptake inhibitors (SSRIs) and neuromodulation techniques such as Deep Brain Stimulation (DBS). SSRIs work by increasing serotonin levels in the brain, which helps to reduce symptoms by modulating mood and anxiety. DBS involves implanting electrodes in specific brain regions, such as the cortico-striato-thalamo-cortical (CSTC) circuit, to deliver electrical impulses that alter abnormal neural activity patterns. These mechanisms are important for OCD patients as they target the underlying neural dysfunctions, providing relief from symptoms and improving quality of life.

What side effects are associated with this type of intervention?

Deep Brain Stimulation (DBS) for OCD, which involves the modulation of neural activity in specific brain regions like the nucleus accumbens, can have side effects such as impulsivity, sleeping problems, and tension. Adjustments to the stimulation parameters are often required to minimize these side effects. Other common treatments for OCD include pharmacotherapy with SSRIs, which can cause nausea, headache, and sexual dysfunction, and cognitive-behavioral therapy (CBT), which may lead to temporary increases in anxiety during exposure exercises. Overall, while DBS shows promise for treatment-resistant OCD, it requires careful management to balance efficacy and side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Obsessive-Compulsive Disorder (OCD), primarily focusing on pharmacological interventions such as selective serotonin reuptake inhibitors (SSRIs) like fluoxetine, sertraline, and clomipramine. For severe, treatment-resistant OCD, the FDA has approved Deep Brain Stimulation (DBS) under a Humanitarian Device Exemption (HDE). DBS involves the modulation of neural activity in specific brain regions, such as the anterior cingulate cortex and the subthalamic nucleus, to alleviate symptoms. This neuromodulation approach is particularly relevant for patients who do not respond to conventional pharmacotherapy and cognitive-behavioral therapy.

What other types of research exist?

Promising, novel alternatives to Deep Brain Stimulation for OCD patients include transcranial direct current stimulation (tDCS). tDCS involves stimulating the cortex with a weak polarizing electric current using electrodes applied to the scalp. This technique is being evaluated for its potential to improve symptoms in treatment-resistant OCD.

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Device

Deep Brain Stimulation for Obsessive-Compulsive Disorder (OBSESS Trial)

N/A

Waitlist Available

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Has failed an adequate trial (150 - 250 mg) of clomipramine

The patient has had at least a five-year history of treatment-refractory OCD that causes substantial subjective distress and impairment in functioning

Must not have

MMSE score < 24

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 14 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort or complications from surgical procedures, changes in mood or behavior due to brain stimulation, headaches, infection risk at the implant site, and possible unknown long-term effects.

Eligibility Criteria

Inclusion Criteria

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

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I have tried clomipramine without success.

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I have had OCD for over 5 years that hasn't improved with treatment and significantly affects my daily life.

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I have tried and not responded to specific antipsychotic drugs.

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I have completed over 20 sessions of a specific therapy for OCD without improvement.

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I have been diagnosed with severe OCD, with a high YBOCS score.

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I am between 21 and 70 years old and not pregnant.

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I have tried at least three SSRIs for 3 months without success.

Exclusion Criteria

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

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My memory and thinking skills test score is below 24.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 14 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 14 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 14 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Hamilton Depression Inventory (HAM-D) Score

Change in Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score

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: Medtronic Percept RC neurostimulatorExperimental Treatment1 Intervention

0 / 8Eligibility 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 pharmacological approaches like selective serotonin reuptake inhibitors (SSRIs) and neuromodulation techniques such as Deep Brain Stimulation (DBS). SSRIs work by increasing serotonin levels in the brain, which helps to reduce symptoms by modulating mood and anxiety. DBS involves implanting electrodes in specific brain regions, such as the cortico-striato-thalamo-cortical (CSTC) circuit, to deliver electrical impulses that alter abnormal neural activity patterns. These mechanisms are important for OCD patients as they target the underlying neural dysfunctions, providing relief from symptoms and improving quality of life.

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