Neurology & Neurosciences Clinical Research

What’s the purpose of the study?

Researchers at Nationwide Children’s Hospital are studying the relationship between cognitive difficulties (difficulties with thinking) after a concussion and a child’s brain waves while they are sleeping.

Who can take part in the study?

You can participate if you:

• Are 13- to 18-years-old
• Have not had a concussion in the last 12 months
• Do not have a diagnosis of ADHD or learning disability

What will happen during the study?

Eligible participants will complete one to two in-person visits at Nationwide Children’s. They will:

• Participate in 45 minutes of cognitive testing
• Complete a 90-minute EEG (brain wave test) during a nap
• Take surveys lasting about 20 minutes
• Keep a log of their sleep for one week

Will we be paid for the study?

Yes, families will be paid for taking part in the study.

For more information or to enroll your child, contact Payton Hummer at (614) 355-1298 or Payton.Hummer@NationwideChildrens.org

Principal Investigator: Sean Rose

What is the DRIVE study?

• The DRIVE study compares three scheduling models of outpatient phyical therapy.

• The goal is to find out the most effective ‘dose’ of phyical therapy for young children with significant gross motor delays.

Who can Participate?

Your child may be eligible if he or she:

• Is 6-24 months of age

• Has a diagnosis of cerebral palsy or severe motor delay

• Is able to participate in 2-hour outpatient physical therapy sessions and attend visits consistently

What is the Treatment?

• This study compares 3 scheduling models of outpatient physical therapy - 5 days a week, 3 days a week, or 1 time a week.

• Physical therapy is provided as 2-hour, one-on-one sessions with a highly qualified, licensed physical therapist at one of the Nationwide Children’s Hospital outpatient settings.

• All families also receive monthly physical therapy consultations with a licensed physical therapist and a personalized home exercise program.

• RISKS: There are no known additional risks of participation in this study beyond the risks of participation in standard outpatient physical therapy. Risks will be discussed fully with each family prior to enrollment.

• COST: Insurance will be billed for each outpatient physical therapy visit. Monthly physical therapy consultations will be provided by the research study. Details will be discussed prior to enrollment.

How do I get More Information?

• For more information please call (614) 572-5446 or email DRIVE@osumc.edu

The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 36 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 240 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS.

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What is the purpose of this study?

Researchers want to learn why youth athletes retire from contact sports after concussion(s) and the effects of this decision on the individual and the family.

Who can take part in the study?

Youth athletes aged 14-22 who stopped playing contact sports due to prior concussion(s), and one parent, may be eligible for this study.

What will happen during the study?

Participants will complete a few short online surveys and one 30-minute phone or video interview.

Will we be paid for the study?

Participants will be compensated for their time.

To learn more, visit https://redcap.nchri.org/surveys/?s=NKTNXLC4WCJMLTP4 or

contact Natasha Hacker at Natasha.Hacker@NationwideChildrens.org or

(614) 722-1389.

Principal Investigator: Sean Rose, MD

Below you will find some basic information about spinal anesthesia (SA) for your child's surgery, including its benefits. While your child is here at Nationwide Children's Hospital, your child's safety and comfort is our primary concern, so please don't hesitate to contact us if you should have any questions that are not answered below.

How a Spinal Anesthetic Works:

• Your anesthesiologist will speak with you about general anesthesia (going to sleep) as compared to spinal anesthesia before the surgery.

• A numbing medicine will be placed on your child’s back to prevent pain associated with the needle.

• When your child is taken into the operating room he/she will be safely placed in the sitting position and comforted by one of our outstanding nursing staff.

• A small needle is used to inject numbing medicine into the back. It is a one-time injection that is very safe, because it is injected well below where the spinal cord is located. This will numb your child from the belly button down. The procedure usually takes less than a minute.

• An IV is placed for safety in one of your child’s feet. He/she will not feel it, because at that point the legs and feet are completely numb.

• While your child is having the operation, he/she is “awake”, but most children are so comfortable that they fall asleep.

• If needed, a small amount of sedation can be given for comfort. We have found that this is rarely needed.

• After the surgery, your child will be taken to the recovery room for a short time. Most children are able to go home very shortly after the procedure, unless an overnight stay is suggested by your surgeon or anesthesiologist.

• General anesthesia is almost never required, but is always available as a backup plan

Benefits of Spinal Anesthesia over General Anesthesia:

• Your child will not need to go to sleep using the traditional method (falling asleep with a mask) and will not need a breathing device (such as a breathing tube). General anesthetics are drugs that keep your child’s whole body asleep.

• Opiates (drugs like morphine) are almost never required.

• Due to the lack of need for general anesthetics and/or opiates, your child will not have his/her breathing depressed after the procedure and will recover much faster.

• Spinal anesthesia provides excellent, long lasting pain control. Most children that have spinal anesthesia only require Tylenol after surgery.

• Your child will be able to eat or breastfeed much sooner than if he/she had general anesthesia.

• Spinal anesthesia carries much less risk than general anesthesia, especially in young children or children with significant medical problems.

Safety of Spinal Anesthesia:

• Spinal anesthesia is very safe. As with any needle procedure (even vaccinations), there is a small risk of bleeding and/or infection. This risk is extremely small and every precaution is taken to ensure safety.

• The risk of other complications is much lower with spinal anesthesia. This includes low blood pressure, problems with the heart or breathing problems. 

What’s the purpose of the study?

The purpose of the study is to determine the effect a diagnosis of epilepsy has on school-aged patients. The study will also look at the impacts of COVID-19 on these families and their school
experience. Researchers hope to be able to provide more support to patients and advocate better for them within the school system.

Who can participate?

Your child can participate if they are:

• 5 to 19-years-old
• Patients of Nationwide Children’s Hospital Neurology Department
• Diagnosed with epilepsy
• English or Spanish speaking

What will happen during the study?

Participants will take a short, one-time survey

For more information or to enroll your child, contact Evelynne Wentzel at (614) 722-2609 or Evelynne.Wentzel@NationwideChildrens.org

Principal Investigator: Dr. Anup Patel

Click Here to Participate

What is the purpose of this study?

We are interested in learning more about which seizure abortive medications work best for families.

Who can participate in this study?

• Any Nationwide Children's Hospital patients who have been prescribed Diastat (Rectal Diazepam) or Versed (Intranasal Midazolam).

What will happen during this study?

• You will answer questions about medical preferences and ease of use.

• The survey should take 5-10 minutes.

• Your participation or lack thereof will not impact your family's care at Nationwide Children's Hospital.

• Patients will be compensated for their time with a $25 Visa gift card.

Who can I contact for more information?

Click here for the research survey.

To learn more or if you have questions, please contact Peter Glynn, Clinical Research Coordinator, at ResearchSeizureSurvey@NationwideChildrens.org.

What is the purpose of this study?

The purpose of this study is to evaluate the effectiveness of a soft mitt constraint on a weaker hand and parent-directed interactions on arm function for young children with hemiplegic cerebral palsy (CP).

Infants and young toddlers in this study will use a non-invasive, soft mitt for Constraint Induced Movement Therapy (CIMT), a therapy that is well-tested in older children with CP, along with specific games and activities.

Image: APPLES Study constraint participant crawling in a session with Helen Carey, PT, DHSc, PCS

• Some of the participants in this study will have CP, while others will not have motor difficulties.

• The study team will test how well a soft mitt used on the more affected hand, along with therapeutic activities taught by physicial therapists (from Nationwide Children's Hospital and The Ohio State University) may help improve motor function for participants with CP.

• Children enrolled in this study that do not have CP will only participate in assessment visits and will not use the soft mitt.

Who can participate in this study?

Infants and toddlers between the ages of 9-27 months at the time of enrollment are eligible for this study, after signed parental consent has been completed.

• Ages 9 to 27 months at the start of the study

• Infants with cerebral palsy who have one side of their body stronger than the other

• Infants without cerebral palsy and no other motor difficulties to participate as controls

Caregivers must be willing to have their child with cerebral palsy wear a soft mitt for six (6) hours at a time and provide two (2) daily at-home sessions lasting 15 minutes each. After the mitt is taken off, caregivers will need to play with their child using two-handed toys as much as possible. Training and support by therapists, as well as materials for activities, will be provided to caregivers.

Caregivers must also be willing to come to Nationwide Children's Hospital for assessments, and transportation will be arranged as needed.

What will happen during this study?

There will be several visits during this study:

• Participants with cerebral palsy will have assessment and training visits.

• Participants without motor difficulties will only have assessment visits.

Assessment appointments will take between 45-60 minutes. During the appointment, research therapists will assess your child using standard movement assessments. A test called "Event-Related Potential (ERP)" will also be performed to measure natural brain electricity and record your infant's brain waves, using soft sensors placed on your child's head with a net, like a shower cap.

At the end of the first assessment visit, therapists will teach caregivers of participants with CP how to do activities at home using the mitts and supplies that we provide.

This study is randomized. This means that young infants and toddlers with CP will be randomly assigned to one of two groups:

• For children with CP, participants in both groups will receive the soft mitt constraint intervention.

• The difference between the two groups will be the timing of the start of these additional therapy services.

  • Your child will continue their regular therapy visits regardless of his/her group study assignment and regardless of his/her participation in the study.

  • In addition to providing materials to caregivers, we will also compensate you for your time.

Who can I contact for more information?

Please contact the APPLES study team, led by Nathalie Maitre, MD, PhD, by phone at (614) 935-6626 or by email at ApplesStudyGroup@NationwideChildrens.org.

Nationwide Children's Hospital is one of forty sites in the United States participating in this multi-center research study designed to find out which of three commonly used, FDA-approved drugs best stops established status epilepticus.

What is Status Epilepticus (SE)?

Status Epilepticus (SE) is a life-threatening condition in which the brain is in a state of persistent seizure. SE is defined as a seizure or recurrent seizures lasting longer than five minutes without stopping or regaining consciousness (waking up).

• There are approximately 120,000-180,000 episodes of SE each year in the United States.

• About one third of SE patients continue to have a seizure despite receiving adequate doses of medicine (benzodiazepines) to make it stop.

• SE affects individuals of all ages, from the very young to the elderly.

What is ESETT?

ESETT is a multi-center emergency medicine study designed to try to save and improve the lives of people who experience a seizure that will not stop on its own or has not responded to a medicine like valium. Emergency Department care of these patients is not the same across the U.S. Because it is not known which drug best treats this type of seizure, different doctors use different medicines.

For this reason, this study (ESETT) plans to look at three commonly used medicines given in the emergency departments for a seizure not stopping: fosphenytoin (fPHT), valproic acid (VPA), and levetiracetam (LVT) to learn which treatment is best at stopping a seizure quickly. All three of these medications are FDA-approved for seizures, which means all patients in the study will be receiving treatment.

How is ESETT different from other studies?

Normally, researchers get permission before a person can be included in a study. A person having a seizure will NOT be able to give consent. Since a seizure that will not stop on its own must be treated quickly, there will not be enough time to locate and talk to the person’s legal representative about the study.

Because of this, all patients will be enrolled in the study without his/her legal representative’s consent. This is called “Exception from Informed Consent” (EFIC). Once the representative is located or the participant wakes up, they will be told about the study and asked to give their permission to continue in the study. For more information on Exception from Informed Consent, please read the last section on this page, entitled What is Exception from Informed Consent (EFIC)?

Why is ESETT important?

The best possible outcomes for seizing patients are likely to depend on a treatment that leads to a rapid stop of the seizure. The reason for doing this study is to find out which of three commonly used drugs is safer and faster at stopping seizures.

Who will be included in the study?

1. Any patient who is two (2) years old or older with an

2. Active recurrent or ongoing seizure lasting longer than five minutes, AND

3. Has already received an adequate dose of benzodiazepine (like valium) in the past 5-30 minutes for a generalized tonic-clonic seizure could be enrolled. 

How will someone be entered into the study?

Every patient coming to the ED who is eligible for the study (if they meet ALL three of the inclusion criteria listed above) will get study treatment.

If you do not wish to be enrolled into the ESETT study, you can wear an "ESETT Declined" bracelet at all times during the study enrollment period (approximately five years, beginning August 2015). If you are wearing this bracelet when you arrive at any participating hospital, researchers will know not to enroll you in this study. If you would like to wear a bracelet to opt out of the ESETT study, please contact the study team or complete this form and submit it by mail.

What are the benefits of this study?

Because we do not know which of the FDA-approved drugs in this study is better, participants may benefit from receiving a better medicine, although this is not guaranteed. Some participants may not get any benefit from being in this research study, but all will be receiving an FDA-approved treatment for their seizures. Additionally, the information obtained from this study may help seizure patients in the future.

What is Exception from Informed Consent (EFIC)?

The U.S. Food and Drug Administration (FDA) is an agency of the federal government that oversees human research involving medicine. The FDA has allowed a set of special rules, called “Exception from Informed Consent” (EFIC), to guide emergency research. EFIC allows research studies to be done in certain emergency situations.

EFIC only applies when:

1. The person's life is at risk, AND

2. The best treatment is not known, AND

3. The study might help the person, AND

4. It is not possible to get permission:

   • from the person, because of his or her medical problem, OR

   • from the person's legally authorized representative because the medical problem must be treated very quickly

Before researchers may do a study using EFIC, they must provide information about the study to the community and get their feedback. This is known as public disclosure and community consultation. The ESETT team at Nationwide Children's Hospital has notified the community about this trial and surveyed the public to ensure clarity and transparency.

Contact Information for the ESETT Study Team at Nationwide Children's

What is the purpose of the study?

This study is a registry for patients with Duchenne Muscular Dystrophy (DMD). Patients with DMD develop cardiomyopathy, or weakening of the heart muscle, and heart failure as the disease progresses. Some patients will experience Sudden Cardiac Death (SCD). Researchers want to find out what the risk of SCD is in patients with DMD. Researchers also want to find out if having an implantable cardioverter-defibrillator (ICD) will benefit patients by preventing SCD related to abnormal heartbeats. They also would like to know if patients with ICD’s suffer complications from the device.

Who can participate in the study?

This study is for patients who are at least 10 years old, have Duchenne Muscular Dystrophy or Becker Muscular Dystrophy, and have a weak heart (ejection fraction less than 55%) or a heart device (for example, a pacemaker or ICD).

What will happen during the study?

During this study, we will collect information about your health from your medical records and record it in an electronic database.

Who can I contact if I am interested or if I have any questions?

If you feel you may be eligible, please call 614-722-0494 or contact the study coordinator, Susan Meyer at Susan.Meyer@NationwideChildrens.org. You may also download the study flyer here.

What is the purpose of the study?

The purpose of this research study is to find the causes of certain epilepsies that begin during childhood or adolescence and have no known causes:

• Juvenile Myoclonic Epilepsy (JME): In this form of epilepsy the patient has myoclonic (muscle) jerks usually of the arms and shoulders, most often in the morning after waking up.

• Juvenile Absence Epilepsy (JAE): In this type of epilepsy the patients have brief spells of staring, each lasting a few seconds. JAE seizures usually start in adolescence but can start as early as about 8 years old. These patients may also experience grand mal seizures.

• Epilepsy with Grand Mal Seizures upon Awakening (AGM): In this type, patients most often have seizures in the morning shortly after awakening or on awakening from a nap. These type of seizures first appear early in adolescence.

• Random Grand Mal (RGM): This is a form of epilepsy in which grand mal seizures can occur any time of day (but usually do not occur in sleep).

Those who take part in the study will be helping to find the causes of certain seizure types and to advance science to better understand the genetic origins of epilepsy and to eventually find a cure.

Who can participate in the study?

Researchers are looking for full families with a family member who started having generalized seizures after the age of 8 years old. Participants can be family members of any age, and the current age of the person with epilepsy does not matter.

What will happen during the study?

The study consists of a short interview about medical/seizure history and a saliva sample from each family member (both the parents and any siblings) of the person with seizures. For an average family of four members, this typically takes about one hour to complete.

Who can I contact if I am interested or if I have any questions?

If you have any questions about the study, you may contact the study coordinator, Sandra Solove, at 614-355-6693 or Sandra.Solove@nationwidechildrens.org.

Purpose of study:

Dizziness is a common symptom following concussion.Often confused as balance problems, symptoms of dizziness may be related to position. Concussion patients often describe a rapid heart rate, lightheadedness, or fainting when they stand. Headaches may be worse with standing. Our study prospectively evaluates predictors of dizziness and ‘orthostatic intolerance’ (symptoms provoked by standing) in an adolescent concussion population.

Who can participate:

Study participation requires:

1. Concussion within 1-12 weeks
2. Concussion symptoms at the time of participation
3. Age range between 12-19 years
4. Referral to the Headache and Pain Clinic at Nationwide Children’s Hospital
5. A normal EKG within the past 6 months
6. A negative pregnancy test (when appropriate)

Patients with known orthostatic intolerance, heart disease, or any medical condition that could impair communication or cause complications during tilt table testing will be excluded.

What will happen during the study:

Study participants will complete several questionnaires about their concussion symptoms, and they will have a tilt table test. The questionnaires cover various symptoms such as dizziness, headaches, memory problems, and changes in mood since the concussion. Parents will be asked about medical problems and any symptoms before the concussion. After completing the questionnaires, we will perform a tilt table test. During the test patients are asked to relax and lie down flat on a table for about 20 minutes. Wires from an electrocardiogram (or EKG) are attached to the chest, blood pressure monitors are attached to the fingers and arms, and straps are gently placed around the body. After 20 minutes, we raise the tilt table to 70 degrees. Patients feel as if they are standing upright. While in the tilted position we ask patients to tell us if they are having any symptoms such as dizziness. Some patients faint during the tilt table test. Our test is shorter than the non-research tilt table test. Most patients will remain in the tilted position for no more than 10 minutes.

Who to contact:

Geoffrey Heyer, MD

E-mail: headacheclinic@nationwidechildrens.org

Purpose of study:

The goal of this study is to understand more about Sturge-Weber Syndrome and the possible treatments for this disease.

Many important clinical questions about SWS remain unanswered or controversial. For example, how does family history impact the clinical manifestation of the individual affected by SWS? What pregnancy exposures or factors occur with increased frequency in individuals with SWS? Which patients would be best served by a hemispherectomy? The answers to these and other questions will eventually be addressed with the aid of the consortium database.

Who can participate: 

You or your child have Sturge-Weber Syndrome brain involvement

What will happen during the study: 

Those participating in the database part of the study will be asked to complete a questionnaire and review their answers at their next appointment with a doctor who cares for SWS.

Who to contact: 

Warren Lo, 614-722-4625 or warren.lo@nationwidechildrens.org