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New treatment option for Obsessive-Compulsive Disorder
Official title Cortical Stimulation to Treat Obsessive Compulsive Disorder
ClinicalTrials.gov ID: NCT04958096
What this study is testing
- What it's testing
- The purpose of this study is to identify abnormal brain signals associated with Obsessive Compulsive Disorder (OCD) and psychiatric symptoms and to investigate novel therapeutic stimulation sites. While treating OCD with standard deep brain stimulation (DBS) therapy, the investigators will also monitor the activity of the anterior cingulate and prefrontal cortex, a region known be involved with OCD, decision making, and emotion regulation, and the investigators will identify abnormal activity corresponding to the severity of a patient's OCD.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- Ability to give informed consent for the study
- Age 22-75
- Clinical diagnosis of OCD
- Documented duration of OCD of at least 5 years
- OCD rated as severe or extreme illness (YBOCs ≥ 28)
You likely can't join if
- Has hoarding as a primary subclassification of OCD according to DSM-4
- Has another severe psychiatric disorder (personality disorder, psychotic/bipolar disorder, etc) or substance abuse issues
- Is pregnant
- Has an abnormal MRI assessed by the team or has a neurological condition requiring an MRI in the future
- Has a cognitive disorder or dementia
- Is at imminent risk for suicide based upon Suicide Severity Rating Scale (SSRS) or has ever attempted suicide
See the full eligibility criteria
- Ability to give informed consent for the study
- Age 22-75
- Clinical diagnosis of OCD
- Documented duration of OCD of at least 5 years
- 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
- Has not responded to adequate trials of cognitive behavior therapy (exposure and response prevention)
- Has not responded adequately to TMS treatment for OCD if it is reasonably available to the patient
- Has hoarding as a primary subclassification of OCD according to DSM-4
- Has another severe psychiatric disorder (personality disorder, psychotic/bipolar disorder, etc) or substance abuse issues
- Is pregnant
- Has an abnormal MRI assessed by the team or has a neurological condition requiring an MRI in the future
- Has a cognitive disorder or dementia
- Is at imminent risk for suicide based upon Suicide Severity Rating Scale (SSRS) or has ever attempted suicide
- Inability to comply with study follow-up visits
- Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
- Allergies or known hypersensitivity to materials in the Activa systems (i.e. titanium, polyurethane, silicone, polyethermide, stainless steel).
- Previous cranial ablative or deep brain stimulation surgery.
- Patients may be excluded from enrollment due to a condition that, in the judgement of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.