RecruitingNot ApplicableNCT06325813

ADHD PreSMA Response Inhibition Therapy


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

40 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control.


Eligibility

Min Age: 12 YearsMax Age: 17 Years

Inclusion Criteria3

  • ADHD diagnosis
  • Ages 12-17 years
  • Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit

Exclusion Criteria11

  • Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, intellectual disability, cerebral palsy, neurodegenerative conditions, hearing impairment, metallic objects in the head or any other serious medical condition
  • Presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants)
  • For biological females who are post-menarche, current pregnancy based on urine pregnancy test.
  • Baseline problem of hearing impairment or chronic tinnitus
  • Any clinically significant finding on brain MRI
  • History of DSM-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder
  • Non-stimulant medication(s) for ADHD (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics)
  • Neuroleptic/antipsychotic medication(s)
  • Inability to undergo MRI
  • Active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician
  • Substance abuse or dependence within the past year, based on 1) separate screening process of asking parent/guardian and participant, and 2) positive urine drug screen. Exception will be made for positive urine drug screen due to prescribed ADHD medication

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEActive repetitive TMS

In this study, ADHD children will receive two trains of intermittent theta burst stimulation. Intermittent theta burst stimulation is a form of repetitive TMS. Both iTBS trains will be active stimulation using the active TMS coil.

DEVICESham repetitive TMS

In this study, ADHD children will receive two trains of intermittent theta burst stimulation. Intermittent theta burst stimulation is a form of repetitive TMS. The first iTBS train will be sham stimulation using the sham TMS coil. The second iTBS train will be active stimulation using the active TMS coil.


Locations(1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06325813


Related Trials