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New treatment option for Obsessive Compulsive Disorder (OCD)
Official title OCD LIFU Target Engagement
ClinicalTrials.gov ID: NCT07558148
What this study is testing
- What it's testing
- The investigators will conduct a pilot study to evaluate the safety and feasibility of low-intensity focused ultrasound on obsessive-compulsive disorder (OCD) symptoms when delivered to subcortical brain targets. The investigators will use the ATTN201 device to deliver single sessions of unfocused and focused ultrasound to up to three brain targets over 4 study visits and assess the intervention through self-rated scales of OCD symptoms.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 1\. Participants must be enrolled in the IRB #853085 study The for the IRB #853085 study, which are also included in this trial are: In order to be...
- Adults aged 18-60 years old
- Chronic OCD (5 years preceding date of enrollment), diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition...
- Presence of obsessions, compulsions, or both time-consuming obsessions and compulsions that take more than one hour a day or cause significant...
- Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5 Severe OCD symptoms, as defined by Y-BOCS I score of...
You likely can't join if
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to undergo MRI scan
- Presence of metallic implants or devices or tattoos
- Claustrophobia or severe anxiety
- Inability to remain still for duration of scan
- Inability to fit and wear the ATTN201 device for the entire Exclusion criteria for IRB study #853085 include:
See the full eligibility criteria
Who can join
- 1\. Participants must be enrolled in the IRB #853085 study The for the IRB #853085 study, which are also included in this trial are: In order to be eligible to participate in this study, an individual must meet all of...
- Adults aged 18-60 years old
- Chronic OCD (5 years preceding date of enrollment), diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)
- Presence of obsessions, compulsions, or both time-consuming obsessions and compulsions that take more than one hour a day or cause significant distress or impairment in social, occupation, or other important areas of...
- Disturbance not better explained by the symptoms of another mental disorder listed in the DSM-5 Severe OCD symptoms, as defined by Y-BOCS I score of 28 or higher, within two weeks prior to enrollment
- Compulsions need to involve movement of the hands and/or arms so that the sleeve is able to detect participant's actions (cannot be solely mental or verbal compulsions)
- Ability to understand procedure-related instructions and to complete study assessments in English, and ability to comply with protocol requirements (e.g., procedure visits, treatment schedule, follow-up visit schedule...
- Willingness and ability to provide written agreement to allow any and all forms of communication between the research team and treating clinician(s) 8 Willingness and ability to provide informed consent, in the opinion...
What rules you out
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to undergo MRI scan
- Presence of metallic implants or devices or tattoos
- Claustrophobia or severe anxiety
- Inability to remain still for duration of scan
- Inability to fit and wear the ATTN201 device for the entire Exclusion criteria for IRB study #853085 include:
- Hearing loss that, in the opinion of the Principal Investigator, an audiologist, or a treating physician, is likely to affect the subject's ability to comply with all of the requirements of the study, or may affect the...
- Pregnancy - this is an exclusion criterion because we will be intentionally increasing anxiety in participants to evaluate optimal strategies to provoke distress and then promote relaxation
- Any past or present medical condition, disease, disorder, or injury that, in the opinion of the Principal Investigator, may reduce or hinder the subject's ability to fully comply with all study requirements for the...
- Have a previous injury or surgery which could affect the nerve distribution
- Have nerve damage (neuropathy)
- Have a diagnosed neuromuscular disorder
- Have a pacemaker
- Have a history of skin allergies, psoriasis eczema, dermatitis, or other skin inflammation conditions
- Compulsions cannot be completely mental or verbal actions, such as repeating words, counting objects, or performing mental rituals, and cannot involve only facial muscles/actions such as blinking or staring
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, 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, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, 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.