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This trial is for people with OCD who have not responded to other treatments. The goal is to use signals from the brain to automatically adjust the Deep Brain Stimulation (DBS) stimulation factors to improve symptom management and reduce stimulation-induced behavioral side effects.
- Obsessive-Compulsive Disorder
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
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Who is running the clinical trial?
- You are a man or woman between the ages of 21 and 70.You have had OCD for at least 5 years that does not respond to treatment and it causes significant distress and problems in your daily life.You have already tried a specific type of therapy called CBT for OCD with an expert therapist for at least 25 hours and it did not work.You are between 21 and 70 years old, regardless of your gender.You have a minimum score of 28 on the Y-BOCS test, which measures the severity of obsessive-compulsive disorder.You have taken certain medications for your mental health, but they did not work well enough. The medications are haloperidol, risperidone, quetiapine, ziprasidone, or aripiprazole.You have a medical or neurological condition that, according to the surgeon, would make you not suitable for the study.You require diathermy or electrical surgical tools during the trial.You have been diagnosed with a mental illness called schizophrenia.You have had a problem with alcohol or drugs within the past 6 months, except for nicotine.Your score on the Y-BOCS test must be at least 28.You have been determined to be at a high risk of thinking about suicide or acting impulsively, based on assessments by medical professionals.You have conditions that make it unsafe for you to undergo an MRI scan.You have already tried clomipramine and it didn't work for you.You have been diagnosed with a mental illness at any point in your life.You have a score of 8 or higher on a test that measures obsessive-compulsive behaviors.You have been diagnosed with a mental illness at any point in your life.You score 8 or higher on a test that measures obsessive-compulsive behaviors.You have a neurological disorder other than essential tremor (like multiple sclerosis, Parkinson's disease, or seizure disorders) or have evidence of brain damage or abnormalities (like tumors, strokes, or traumatic brain injuries).You have a long-term diagnosis of Essential Tremor, except if it affects only your head, and you have a deep brain stimulation (DBS) implant.People with OCD who are not eligible for deep brain stimulation (DBS) treatment will be excluded.You have a medical condition or situation that makes it unsafe for you to have an MRI scan.People who can participate in the study for OCD deep brain stimulation (DBS) must meet the following requirements:You have been experiencing severe, treatment-resistant OCD for at least five years, which greatly impacts your daily life and causes significant distress.You have a condition that makes it unsafe for you to undergo an MRI scan.You have a neurological disorder like multiple sclerosis (MS), Parkinson's disease, or seizure disorders. You also have evidence of brain abnormalities or injury, such as a tumor, stroke, or traumatic brain injury.You have already tried a type of therapy called CBT for OCD, where you worked with a therapist for at least 25 hours on exposure and response prevention.I'm sorry, but the provided criterion seems to be incomplete. Could you please provide more details or clarify the inclusion criteria for implanted ET subjects?
- Group 1: Activa PC+S DBS implant for OCD
- Group 2: One Month Blinded Discontinuation Period
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
To what extent is this trial open to participants?
"This research project is only available to people between 21 and 70 who have been diagnosed with obsessive-compulsive disorder. The clinical trial will accept up to two participants for the study."
Are there any openings left in this clinical research project?
"The information listed on clinicaltrials.gov attests that this medical trial is not presently recruiting patients. Initially advertised in July 2018, it was last updated a few months ago in February 2022. Despite the cessation of patient recruitment for this particular study, there are 114 other trials actively enrolling participants at present."
Is this study inclusive of geriatric participants?
"As per the stipulations of this trial, prospective enrollees should be within the age range of 21 to 70. 23 trials are available for younger patients while 67 studies are open to those over 65 years old."
Who else is applying?
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How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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