Clinical trial NCT06325813: ADHD PreSMA Response Inhibition Therapy
Official title: ADHD PreSMA Response Inhibition Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Transcranial Magnetic Stimulation
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: TMS-based Short-Interval Intracortical Inhibition (SICI)
timeFrame: Immediately after each iTBS train
measure: EEG-based beta activity
timeFrame: Immediately after each iTBS train
measure: TMS-based Cortical Silent Period (cSP)
timeFrame: Immediately after each iTBS train
measure: EEG-based alpha activity
timeFrame: Immediately after each iTBS train
Secondary outcomes:
measure: Stop Signal Reaction Time
timeFrame: Immediately after each iTBS train
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Steve W Wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: