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RECRUITINGINTERVENTIONAL

ADHD PreSMA Response Inhibition Therapy

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. ADHD diagnosis 2. Ages 12-17 years 3. Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit Who Should NOT Join This Trial: 1. 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 2. Presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants) 3. For biological females who are post-menarche, current pregnancy based on urine pregnancy test. 4. Baseline problem of hearing impairment or chronic tinnitus 5. Any clinically significant finding on brain MRI 6. History of DSM-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder 7. Non-stimulant medication(s) for ADHD (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics) 8. Neuroleptic/antipsychotic medication(s) 9. Inability to undergo MRI 10. Active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician 11. 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. ADHD diagnosis 2. Ages 12-17 years 3. Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit Exclusion Criteria: 1. 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 2. Presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants) 3. For biological females who are post-menarche, current pregnancy based on urine pregnancy test. 4. Baseline problem of hearing impairment or chronic tinnitus 5. Any clinically significant finding on brain MRI 6. History of DSM-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder 7. Non-stimulant medication(s) for ADHD (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics) 8. Neuroleptic/antipsychotic medication(s) 9. Inability to undergo MRI 10. Active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician 11. 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

Treatments Being Tested

DEVICE

Active 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.

DEVICE

Sham 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