ADHD PreSMA Response Inhibition Therapy

Last updated: September 3, 2024
Sponsor: Children's Hospital Medical Center, Cincinnati
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism Spectrum Disorder (Asd)

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Williams Syndrome

Treatment

Sham repetitive TMS

Active repetitive TMS

Clinical Study ID

NCT06325813
CIN001 - ADHD PreSMART
  • Ages 12-17
  • All Genders

Study 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 Criteria

Inclusion

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 daysof TMS visit

Exclusion

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, cerebralpalsy, neurodegenerative conditions, hearing impairment, metallic objects in thehead 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 urinepregnancy 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 bya study physician

  11. Substance abuse or dependence within the past year, based on 1) separate screeningprocess of asking parent/guardian and participant, and 2) positive urine drugscreen. Exception will be made for positive urine drug screen due to prescribed ADHDmedication

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Sham repetitive TMS
Phase:
Study Start date:
September 03, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

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