The study is titled Anomalous Motor System Physiology in ADHD: Biomarker Validation and Modeling Domains of Function Using Transcranial Magnetic Stimulation (TMS). Compensation is $50/visit, two or three visits.
This research study investigates neural biomarkers (specific electrical patterns) in areas of the brain that control muscle movement and movement planning in children 8 to 12 years old. More specifically, this research study aims to understand the differences in these neural patterns in children with attention deficit/hyperactivity disorder (ADHD). Participation in this study requires either two or three full-day research appointments (typically 8:30 a.m. to 3 p.m.). During the research appointments, your child will complete achievement assessments, surveys about their behavior and routines, computer-based activities assessing cognitive functions like memory, planning, and response control, and movement activities assessing motor control, balance, aiming, and catching. These activities allow us to understand the relationships between movement-based development and cognitive development. Additionally, your child will complete multiple sessions of transcranial magnetic stimulation (TMS). Children with ADHD will complete either two or four sessions of TMS. Children without ADHD will complete two sessions of TMS.
Lastly, you and your child will complete surveys about their behavior and routines. Parents will also be asked to send surveys to their child's teacher, if attending public or private school, that collect additional information about their child's behavior and routines. Teacher surveys are collected September through June.
Transcranial Magnetic Stimulation. TMS uses a hand-held magnet, similar to the magnet used for MRI scans, which allows us to briefly stimulate a specific area of the brain. The magnet is held over the scalp of the participant, and a brief, small magnetic pulse is generated. The magnetic pulse causes the brain cells in that area to activate and send an electrical signal through the brain. This magnetic pulse mimics the electrical signal that brain cells create when a person decides to move part of their body.
In this study, we place the magnet over the area of the brain that controls hand movement. When we generate the magnetic pulse, it causes a twitch in the participant's finger. By studying the way children's brains respond to this magnetic pulse, we can learn about the neural mechanisms that control body movement and affect motor development. By using TMS, we can compare the development of these neural mechanisms and brain areas in children with and without ADHD.
Our center has been using TMS as research tool since 2001 and, to date, we have enrolled more than 100 children into research studies that use TMS. TMS is a painless, noninvasive procedure. Prior to your child's first TMS session, they will have an opportunity to see the machine, meet our technicians, and see the magnetic pulse applied to one of our staff. This approach helps alleviate worries around the procedure and helps the child feel comfortable during the sessions.
TMS does not allow us to diagnose any specific brain diseases.
Stimulant Medications. As part of the research study, we aim to capture the differences associated with neurodevelopmental disorders and collect information on behavioral patterns unaffected by medication treatments. If your child is taking a stimulant medication, including but not limited to methylphenidate, dexmethylphenidate, Ritalin, Vyvanse, Adderall, Focalin, Concerta and/or Daytrana, they will need to withhold their medication the day before and the day of their research appointment. There is minimal risk associated with withholding stimulant medication for a short period of time, though your child may experience increased difficulty focusing and increased hyperactivity and impulsivity on these days. Participants can resume taking their stimulant medication as prescribed after their research appointment. Participants can continue taking nonstimulant medication (guanfacine, Strattera, Qelbree, Intuniv, Tenex) and other medications (allergy medication, Zoloft, citalopram, etc.) as prescribed.
Time Commitment. Participants will complete two or three research appointments at our center. Research visits are typically scheduled from 8:30 a.m. to 3 p.m. Research appointments must occur 10-21 days apart. Parents will complete surveys about their child; surveys can take up to four hours to complete.
Compensation. Children can earn up to $100 for completing this research study. Additional prizes (small toy and/or $5 Amazon gift card) are available for children based on their performance on computer-based activities. Families can choose to receive their payment in the form of an Amazon gift card or check. Checks are mailed to the family and typically arrive 2-4 weeks after the final research appointment.
Optional Component (participants with ADHD only): Understanding How Medication Affects Motor Control. Children with ADHD can elect to participate in an additional component of this research study that includes taking 10 mg of methylphenidate and a placebo (sugar pill). The purpose of this component is to assess the impact of stimulant medication on motor control. Children who complete this component of the research study will complete three research appointments.
During the first appointment, participants complete their achievement assessments, computer-based activities, and movement activities. During their second and third appointments, participants complete a two-hour TMS session in the morning, take either a placebo (sugar pill) or 10mg of methylphenidate during their one-hour lunch break, and then complete a two-hour TMS session in the afternoon. Children already taking stimulant medication withhold their medication on their appointment days. Participants with ADHD who elect to complete the medication component receive an additional $50 for the additional day of testing.
To register your child for the study or to get more information, contact the Center for Neurodevelopmental and Imaging Research at CNIR@kennedykrieger.org.
