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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failed an adequate trial of at least three of the following SSRIs: Fluoxetine, fluvoxamine, citalopram, escitalopram, sertraline, paroxetine
Failed augmentation of one or more of the aforementioned drugs with at least one of the following antipsychotics: haloperidol, risperidone, quetiapine, ziprasidone, aripiprazole
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upmonth 18
Awards & highlights
No Placebo-Only Group
Study Summary
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.
Eligible Conditions
- Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
People who can participate in the study for OCD deep brain stimulation (DBS) must meet the following requirements:
Select...
You have been experiencing severe, treatment-resistant OCD for at least five years, which greatly impacts your daily life and causes significant distress.
Select...
Your score on the Y-BOCS test must be at least 28.
Select...
You have already tried clomipramine and it didn't work for you.
Select...
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.
Select...
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?
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of subjects that display biomarkers of DBS-induced hypomania
Percent of subjects that display biomarkers of OCD-related distress
Secondary outcome measures
Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Rating OCD Symptom Severity
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: One Month Blinded Discontinuation PeriodExperimental Treatment1 Intervention
all subjects will enter a one-month blinded discontinuation period to confirm clinical benefit at the end of Month 8.
Group II: Activa PC+S DBS implant for OCDExperimental Treatment1 Intervention
all subjects will receive surgical implantation of DBS system
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,316 Previous Clinical Trials
644,179 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
5,008 Patients Enrolled for Obsessive-Compulsive Disorder
Brown UniversityOTHER
444 Previous Clinical Trials
525,881 Total Patients Enrolled
8 Trials studying Obsessive-Compulsive Disorder
467 Patients Enrolled for Obsessive-Compulsive Disorder
University of PittsburghOTHER
1,685 Previous Clinical Trials
16,303,896 Total Patients Enrolled
6 Trials studying Obsessive-Compulsive Disorder
152 Patients Enrolled for Obsessive-Compulsive Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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?
Research Study Groups:
This trial has the following groups:- Group 1: Activa PC+S DBS implant for OCD
- Group 2: One Month Blinded Discontinuation Period
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
Who else is applying?
What state do they live in?
Texas
North Carolina
How old are they?
18 - 65
What site did they apply to?
University of Pittsburgh
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have harm ocd which is very lonely I can’t really talk to anyone about except a therapist.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
I’d like to know how many treatments?
PatientReceived 2+ prior treatments
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