ADHD PreSMA Response Inhibition Therapy

NCT06325813 | Recruiting FDA Device

• 1 other identifier: CIN001 - ADHD PreSMART
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (4)

• TMS-based Short-Interval Intracortical Inhibition (SICI)

  This is a measure of primary motor cortex inhibitory activity.

  Immediately after each iTBS train

• EEG-based beta activity

  This is a measure of beta-band activity during performance of stop signal task.

  Immediately after each iTBS train

• TMS-based Cortical Silent Period (cSP)

  This is a measure of primary motor cortex inhibitory activity.

  Immediately after each iTBS train

• EEG-based alpha activity

  This is a measure of alpha-band activity during performance of stop signal task.

  Immediately after each iTBS train

Secondary Outcomes (1)

• Stop Signal Reaction Time

  Immediately after each iTBS train

Study Arms (2)

Active repetitive TMS

ACTIVE COMPARATOR

Device: Active repetitive TMS

Sham repetitive TMS

SHAM COMPARATOR

Device: Sham repetitive TMS

Interventions

Active repetitive TMS DEVICE

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.

Active repetitive TMS

Sham repetitive TMS DEVICE

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.

Sham repetitive TMS

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ADHD diagnosis
• Ages 12-17 years
• Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Steve W Wu, M.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karlee Migneault, B.A.

CONTACT

513-803-5299; Karlee.Migneault@cchmc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: March 22, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)