7 to 17 Year Olds with Obsessive Compulsive Disorder (OCD) Needed for a Research Study

Why are we doing this research?

Cincinnati Children’s is conducting a research study, sometimes known as a clinical trial or clinical study, to learn more about how the brain works in children who have Obsessive Compulsive Disorder (OCD). We also hope to learn how to give better care to each child based on what is best for them individually.

We will use a non-invasive test called an MEG to measure the activity in the brain and tell us if there are changes or irregularities in this activity between someone who has OCD and someone who doesn’t.

Who can participate?

Children, 7 to 17 years old, who have OCD and: 

    • Have a contamination obsession
    • Are right-handed
    • Have never been on any medication for their OCD but are interested in considering treatment, such as sertraline (Zoloft®) 

Anyone with other neurological or psychiatric disorders (like epilepsy or ADHD), or who has a non-removable implant or metal device (like a cochlear implant, pacemaker, permanent retainer or braces) will NOT be able to participate.

 

Conditions

  • Anxiety Disorders
  • Mental Health

What will happen in the study?

If your child qualifies, and you and your child decide you want him/her to be in the study, your child will come to Cincinnati Children’s for 4 study visits over 12 weeks. You and/or child will participate in 1 questionnaire and consent visit and 3 MEG/EEG scan visits, 1 of which will include an MRI. These procedures will be at no cost to you or your insurance company and are covered by the research study.

The following is a list of some of the procedures that will happen during this study:

 

    • Informed Consent/Assent: We will go over the informed consent or assent form to make sure you and your child understand what will happen during this research study and ask if you have any questions. We will have you and/or your child sign the informed consent/assent.
    • Child and Parent Anxiety Disorders Interview: This interview is to confirm your child’s diagnosis of OCD and will be recorded.
    • Intelligence test: This is a short test to determine verbal and non-verbal IQ.
    • Handedness test: This will confirm your child’s dominate hand.
    • Self-Assessment test: This test will assess your child’s developmental stage.
    • Demographic data: We will ask questions to collect information about you, including your age, education and family income.
    • Medical and psychiatric history: We want to know more about your child’s current and past medical and psychiatric condition.
    • Suicide risk factors: As an extra safety measure, we will collect/ask you about risk factors for suicide, including depression, substance abuse, prior suicide attempts, family history of suicide, and exposure to the suicide behavior of others.
    • Anxiety inventory: This is done to assess your child’s level of anxiety.
    • OCD scale: This measures your child’s OCD symptom severity and will be recorded.
    • Global impression scale: This will measure symptom severity, improvement and if the treatment seems to be working.
    • Global assessment scale: This test rates your child’s general functioning.
    • Suicide severity rating scale: This is for suicide assessment.
    • Adverse event rating scale: This is to assess for adverse events.
    • Urine sample: We will take a urine sample for drug screening and pregnancy tests (for females).
    • Magnetic Resonance Imaging (MRI): Your child will lie down in a scanner for about 20 minutes while a machine takes pictures of the brain. 
    • Electroencephalography (EEG): Electrodes will be placed on your child’s head with non-permanent paste to measure the electrical activity in the brain. 
    • Magnetoencephalography (MEG): The MEG will “listen” to your child’s brain activity. 

 

These are some of the things that will happen for the MEG, EEG and/or MRI:

 

    • Head Measurement: Your child’s head will be measured to determine if it will fit the specifications of the inside of the helmet (gantry) for the MEG/EEG. If it is determined that your child’s head is not a good fit, you will be informed that your child has not been selected for testing. 
    • De-Metaling: We will ask you to remove any metallic/magnetic objects from your child’s person before entering the Magnetically Shielded Room (MSR). 
    • Coil Placement: Coils will be placed to determine the position of your child’s head in the helmet and to determine the amount of head movement during testing.
    • Magnetically Shielded Room (MSR): Your child will be placed in the MSR, which is designed to shield out magnetic interference.
None of these machines will hurt your child.

Parents interested in having their child participate will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

 

What are the good things that can happen from this research?

Your child may or may not receive any direct benefit from participating in this study. We hope that results of this study may help children with OCD later on.

What are the bad things that can happen from this research?

The MEG/EEG machine has wires that are connected to stickers or electrodes (a flat piece of metal) that are put on your child’s skin using a gel or liquid glue (the gel may smell bad). The electrodes will pull like tape when they come off. Sometimes kids get red spots from the tape coming off. The red spots should go away in a day or two.

At the beginning of the study, you will be with your child in the MEG/EEG room. After you step out of the room, your child may feel lonely, bored or sleepy. We will be able to see your child in the MEG room and your child can talk to us on a microphone if anything is bothering them.

Also, the noise that an MRI makes can cause discomfort. Headphones will be provided to reduce the level of noise.

A full, detailed list of possible side effects will be provided to those participants, parents or guardians interested in knowing more about this study.

Will you/your child be paid to be in this research study?

Participants will receive up to $100 for their time and travel.

Contact

Contact Us.Elana Harris
513-636-2100
elana.harris@cchmc.org
Cincinnati Children’s Hospital Medical Center
Division of Child Psychiatry
3333 Burnet Avenue
Cincinnati, OH 45229-3039

Study Doctor

Contact Us.Elana Harris, MD, PhD
Cincinnati Children’s Hospital Medical Center
Division of Child Psychiatry