OCD Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older
• You have been formally diagnosed with Obsessive-Compulsive Disorder (OCD) as your primary mental health condition
• You meet the FDA's special approval requirements for this type of brain stimulation device used for OCD
• Your doctors have already decided — separately from this study — that you should receive a specific type of brain stimulation treatment (DBS with a directional system) for your OCD
• You have had severe OCD that has not responded to treatment for at least five years, significantly affecting your daily life
• You have tried and not responded to at least three of the following antidepressants: Fluoxetine, Fluvoxamine, Citalopram, Escitalopram, Sertraline, or Paroxetine
• You have tried and not responded to a medication called clomipramine
• You have tried at least one of the above antidepressants combined with an additional medication (such as Haloperidol, Risperidone, Olanzapine, Quetiapine, Ziprasidone, or Aripiprazole) without sufficient benefit
• You have completed at least 25 hours of a specific type of talking therapy for OCD (called Cognitive Behavioral Therapy/Exposure and Response Prevention) with a qualified therapist, and it has not worked well enough
• Your OCD symptoms score at least 25 on a standard OCD severity scale (Y-BOCS) before any surgery
• You are able to have an MRI scan before surgery
• You are able to read and communicate in English
• You are able to understand and sign a consent form agreeing to take part
• You are willing and able to follow all study procedures and instructions for the device

Who may not be able to join:

• You are not eligible for, or do not want to receive, the brain stimulation treatment (ALIC DBS) for OCD
• You have medical reasons that prevent you from having general anesthesia, brain surgery, or an MRI scan
• You have a neurological condition or significant brain problem, such as notable brain shrinkage, stroke, brain tumour, epilepsy, or have had previous brain surgery (a prior procedure called cingulotomy may still be acceptable — confirm with trial site)
• You have an unstable or serious physical health condition, a condition that requires long-term immune system suppression, or a significantly shortened life expectancy
• You need blood-thinning medication that cannot be safely stopped around the time of surgery
• You have a condition that requires you to have regular MRI scans or a heat-based medical treatment called diathermy
• You currently have a heart pacemaker, defibrillator, or another implanted electrical device that could interfere with the brain stimulation device (confirm with trial site)
• You have another major mental health condition such as schizophrenia or a history of psychosis
• You have had a problem with alcohol or drug misuse or dependence in the six months before the brain surgery (tobacco and caffeine are not included in this)
• You are currently having thoughts of suicide with intent to act, have attempted suicide in the last six months, have made more than three suicide attempts in the last two years, or are considered to be at serious risk of suicide by the study doctors
• You have a personality disorder that, in the opinion of the study psychiatrist, could increase the risks of the treatment or make it difficult to follow the study requirements (confirm with trial site)
• You are not able to properly manage and maintain the device, as judged by the research team
• You are currently pregnant

Important: Always verify eligibility with the trial site directly before applying.