ADHD PreSMA Response Inhibition Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorChildren's Hospital Medical Center, Cincinnati
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ADHD diagnosis
Ages 12-17 years
Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Active repetitive TMS
DeviceIn 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.
Sham repetitive TMS
DeviceIn 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active repetitive TMSActive comparator 1 intervention
Group B: Sham repetitive TMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
TMS-based Short-Interval Intracortical Inhibition (SICI)
This is a measure of primary motor cortex inhibitory activity.
Time frame
Immediately after each iTBS train2
EEG-based beta activity
This is a measure of beta-band activity during performance of stop signal task.
Time frame
Immediately after each iTBS train3
TMS-based Cortical Silent Period (cSP)
This is a measure of primary motor cortex inhibitory activity.
Time frame
Immediately after each iTBS train4
EEG-based alpha activity
This is a measure of alpha-band activity during performance of stop signal task.
Time frame
Immediately after each iTBS trainSecondary outcomes
1
Stop Signal Reaction Time
This is a measure calculated from the stop signal task. This is an experimental measure of how well the participant can inhibit a motor action.
Time frame
Immediately after each iTBS trainSponsors and contacts
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Source ClinicalTrials.gov