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Behavioural Intervention

Brain Stimulation for Obsessive-Compulsive Disorder

N/A
Recruiting
Led By Andrew M Lee, MD, PhD
Research Sponsored by Andrew Moses Lee, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
OCD rated as severe or extreme illness (YBOCs ≥ 28)
Has failed to improve following treatment with at least two selective serotonin reuptake inhibitors (SSRIs), clomipramine, and augmentation with antipsychotics
Must not have
Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
Previous cranial ablative or deep brain stimulation surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking for better ways to treat OCD by identifying abnormal brain signals associated with the disorder and psychiatric symptoms, and investigating whether novel therapeutic stimulation sites can help improve OCD symptoms.

Who is the study for?
This trial is for adults aged 22-75 with severe or extreme OCD (YBOCs ≥ 28) who haven't improved after cognitive behavior therapy, two types of antidepressants, and antipsychotics. Candidates should not have responded to TMS if available, must be able to consent, and have had OCD for at least 5 years.
What is being tested?
The study tests whether stimulating the prefrontal cortex (PFC) or anterior cingulate cortex (ACC), in addition to standard deep brain stimulation (DBS), can improve symptoms in OCD patients. It involves implanting electrodes and recording brain activity during different tasks over up to two years.
What are the potential side effects?
Potential side effects may include discomfort from electrode implants, risks associated with surgery such as infection or bleeding, changes in mood or behavior due to stimulation, and possible device-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My OCD is severe, with a YBOCs score of 28 or higher.
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I haven't improved after treatment with two SSRIs, clomipramine, and antipsychotics.
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I have tried cognitive behavior therapy without improvement.
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I have had OCD for at least 5 years.
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I have been diagnosed with OCD.
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I am between 22 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious health condition like severe high blood pressure or diabetes that could make surgery risky.
Select...
I have had brain surgery or deep brain stimulation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 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 Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from 12 months to 24 months
Secondary study objectives
Change in Montgomery Asberg Depression Rating Scale (MADRS) score from 12 months to 24 months
Other study objectives
Biomarker identification in Stage 1

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Prefrontal Cortex (PFC)Experimental Treatment2 Interventions
The Prefrontal Cortex (PFC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the PFC.
Group II: Anterior Cingulate Cortex (ACC)Experimental Treatment2 Interventions
The Anterior Cingulate Cortex (ACC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the ACC.

Find a Location

Who is running the clinical trial?

Andrew Moses Lee, MD, PhDLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
10 Patients Enrolled for Obsessive-Compulsive Disorder
Andrew M Lee, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Cortical Stimulation for ACC (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04958096 — N/A
~5 spots leftby Aug 2026
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