ADHD PreSMA Response Inhibition Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active repetitive TMS, Sham repetitive TMS.
- Who it may be relevant to
- Registry conditions: Attention Deficit Hyperactivity Disorder. Basic parameters: 12 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
ADHD children (ages 12-17 years) will be recruited. Cognitive testing and basic anatomic brain MRI will be performed during visit 1. During visit 2, baseline TMS-based physiologic measures will be obtained. Children will also complete a behavioral task (stop signal task) while electroencephalography (EEG) data is collected. After these baseline measures, two trains of Intermittent Theta Burst Stimulation (iTBS) will be delivered. (Intermittent Theta Burst Stimulation is a form of repetitive TMS.) The first train of iTBS will be randomized to sham vs. active in a 1:1 ratio. The second train of iTBS is active for all participants. After both iTBS trains are completed, repeat TMS-based measures, stop signal task and EEG data will be collected again. Visit 3 will be one week after visit 2. Visit 3 is a virtual computer-based visit to assess for any potential side effects.
Interventions
- 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.
Primary outcome measures
- TMS-based Short-Interval Intracortical Inhibition (SICI) [Time frame: Immediately after each iTBS train]
- EEG-based beta activity [Time frame: Immediately after each iTBS train]
- TMS-based Cortical Silent Period (cSP) [Time frame: Immediately after each iTBS train]
- EEG-based alpha activity [Time frame: Immediately after each iTBS train]
Secondary outcome measures (1)
- Stop Signal Reaction Time [Time frame: Immediately after each iTBS train]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT06325813 · CIN001 - ADHD PreSMART