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 alleviate OCD symptoms. DBS, particularly targeting the anterior limb of the internal capsule (ALIC), involves implanting electrodes that send electrical impulses to modulate brain circuits linked to OCD. This is crucial for patients with treatment-resistant OCD, as it offers a more precise and potentially effective intervention by directly altering dysfunctional brain activity.

What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include both non-invasive and invasive neuromodulation therapies. Non-invasive therapies like repetitive transcranial magnetic stimulation (TMS) can cause side effects such as headaches, scalp discomfort, and, rarely, seizures. Invasive therapies like Deep Brain Stimulation (DBS), particularly targeting the anterior limb of the internal capsule (ALIC), may lead to side effects including infection, bleeding, hardware complications, and transient psychiatric symptoms such as impulsivity, sleeping problems, or tension. Adjustments to the stimulation parameters can mitigate some of these 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 fluvoxamine, as well as the tricyclic antidepressant clomipramine. For treatment-resistant OCD, the FDA has approved deep brain stimulation (DBS) targeting the anterior limb of the internal capsule (ALIC), which modulates brain circuits associated with OCD symptoms. This neuromodulation approach is particularly considered for patients who do not respond to conventional therapies.

What other types of research exist?

Promising, novel alternatives to DBS for OCD patients include Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depressive relapses and may be beneficial for OCD. Transcranial Direct Current Stimulation (tDCS) is another option, with studies indicating its potential in enhancing neurocognition and reducing symptoms. Additionally, Cranial Electrotherapy Stimulation (CES) has demonstrated safety and efficacy in pilot studies for bipolar depression, suggesting it may also be useful for OCD.

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Deep Brain Stimulation

Deep Brain Stimulation for Obsessive-Compulsive Disorder

N/A

Waitlist Available

Led By Ki Sueng Choi

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Failure of an adequate trial of one or more of the aforementioned antidepressants in combination with at least one of the following augmentation agents: Haloperidol, Risperidone, Olanzapine, Quetiapine, Ziprasidone, Aripiprazole

Minimum of a five-year history of treatment-refractory OCD with substantial functional impairment

Must not have

Contraindications for general anesthesia, neurosurgery, or an MRI scan

Other primary Axis I disorder or history of psychosis, such as schizophrenia, psychosis in the context of depressive or manic episode

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative months 0, 6, 12

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a technique called deep brain stimulation (DBS) to help people with severe OCD who haven't improved with other treatments. Electrodes are placed in a specific brain area to send electrical impulses that adjust brain activity and reduce symptoms. The study aims to personalize the stimulation for each patient to maximize benefits.

Who is the study for?

This trial is for adults with severe OCD who haven't improved after trying multiple treatments, including at least three types of SSRIs, clomipramine, antipsychotic augmentation agents, and extensive CBT. They must score at least 25 on the Y-BOCS scale and be able to undergo MRI scans. Pregnant women or those with certain medical conditions or psychiatric diagnoses that increase risks are excluded.

What is being tested?

The study tests personalized deep brain stimulation (DBS) targeting the ALIC region in the brain for OCD patients. It aims to find specific neural pathways linked to individual symptoms and stimulate them precisely for better treatment outcomes.

What are the potential side effects?

Potential side effects may include discomfort from device operation, headache or pain from surgery, mood changes due to brain stimulation, movement disorders or speech issues related to DBS settings adjustments.

Eligibility Criteria

Inclusion Criteria

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

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I've tried antidepressants with specific additional medications without success.

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I have had OCD for over 5 years and it significantly affects my daily life.

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I can have an MRI before surgery.

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I have tried at least three different SSRIs without success.

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I have completed 25 hours of CBT without improvement.

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I have been diagnosed with OCD.

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I am 18 years old or older.

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I have tried clomipramine without success.

Exclusion Criteria

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

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I cannot have general anesthesia, neurosurgery, or an MRI scan due to health reasons.

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I do not have a history of major mental health disorders like schizophrenia.

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I am currently pregnant.

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I am not willing or cannot have deep brain stimulation for OCD.

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I need anticoagulant therapy that can't be stopped for surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative months 0, 6, 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative months 0, 6, 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative months 0, 6, 12 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 Yale Brown Obsessive Compulsive Scale (Y-BOCS)

Secondary study objectives

Change in Barratt Impulsiveness Scale (BIS-11)

Change in Beck Anxiety Inventory (BAI)

Change in Beck Depression Inventory (BDI)

+7 more

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: Circuit-selective DBSExperimental Treatment1 Intervention

People suffering from severe obsessive-compulsive disorder (OCD)

0 / 13Eligibility 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 alleviate OCD symptoms. DBS, particularly targeting the anterior limb of the internal capsule (ALIC), involves implanting electrodes that send electrical impulses to modulate brain circuits linked to OCD. This is crucial for patients with treatment-resistant OCD, as it offers a more precise and potentially effective intervention by directly altering dysfunctional brain activity.

Deep-brain stimulation in treatment-resistant obsessive-compulsive disorder: Clinical and molecular neuroimaging correlation.