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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative months 0, 6, 12
Awards & highlights

Study 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.

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)

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
861 Previous Clinical Trials
525,256 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
60 Patients Enrolled for Obsessive-Compulsive Disorder
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,747 Total Patients Enrolled
65 Trials studying Obsessive-Compulsive Disorder
13,961 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research recruiting participants currently?

"Yes, the data hosted on clinicaltrials.gov verifies that this medical trial is recruiting participants. This investigation was initially posted online in August 2021 and recently modified October 2022; it requires 20 patients to be acquired at one centre of study."

Answered by AI

How many individuals are participating in this experiment?

"Confirmed. The trial's information on clinicaltrials.gov indicates that it is presently recruiting patients, having been first posted on August 13th 2021 and last edited on October 24th 2022. This medical experiment necessitates the recruitment of 20 individuals from one healthcare facility."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
Mount Sinai West
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder
Martijn Figee 2021. "Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05160129.
All > Ocd New York > Ocd
~8 spots leftby Mar 2026
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