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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-24 months

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

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) from 12 months to 24 months

Secondary outcome measures

Change in Montgomery Asberg Depression Rating Scale (MADRS) score from 12 months to 24 months

Other outcome measures

Biomarker identification in Stage 1

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.

0 / 6Eligibility criteria met

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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

Frequently Asked Questions

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

Is it possible to currently enroll in the research?

"Confirmed, clinicaltrials.gov currently lists this medical trial as open to participants; it was opened on August 1st 2021 and last modified on November 21st 2022."

Answered by AI

Is enrollment open for geriatric patients into this research?

"This medical trial is looking for participants aged between 22 and 75."

Answered by AI

Is enrollment in this experiment open to new participants?

"Prospective participants for this trial must have a diagnosis of obsessive-compulsive disorder and be between the ages of 22 to 75. There are around 15 slots open at present."

Answered by AI

What is the sample size of this clinical investigation?

"Affirmative. Clinicaltrials.gov's information reveals that this research is actively recruiting for participants, beginning on August 1st 2021 and most recently edited November 21st 2022. 15 people are sought from 2 distinct medical centres to partake in the trial."

Answered by AI