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Deep Brain Stimulation

Deep Brain Stimulation for Obsessive-Compulsive Disorder

N/A
Recruiting
Led By Martijn Figee
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

Summary

This trial is testing a new method of deep brain stimulation (DBS) for people with severe OCD whose symptoms have not improved with other treatments. The target is the anterior limb of the internal capsule (ALIC) brain region. On average, 60% of all OCD patients have a clinically significant response to ALIC DBS. However, this method may become even more effective with the ability to predict which specific ALIC connections in the brain need to be stimulated for each individual OCD patient.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Secondary outcome measures
Change in Barratt Impulsiveness Scale (BIS-11)
Change in Beck Anxiety Inventory (BAI)
Change in Beck Depression Inventory (BDI)
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Circuit-selective DBSExperimental Treatment1 Intervention
People suffering from severe obsessive-compulsive disorder (OCD)

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.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
871 Previous Clinical Trials
527,252 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
60 Patients Enrolled for Obsessive-Compulsive Disorder
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,799 Total Patients Enrolled
65 Trials studying Obsessive-Compulsive Disorder
13,902 Patients Enrolled for Obsessive-Compulsive Disorder
Martijn FigeePrincipal InvestigatorIcahn School of Medicine and Mount Sinai

Media Library

Connectomic Deep Brain Stimulation (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05160129 — N/A
Obsessive-Compulsive Disorder Research Study Groups: Circuit-selective DBS
Obsessive-Compulsive Disorder Clinical Trial 2023: Connectomic Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT05160129 — N/A
Connectomic Deep Brain Stimulation (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05160129 — N/A
~7 spots leftby Mar 2026