RECRUITING

ADHD PreSMA Response Inhibition Therapy

Conditions

Attention Deficit Hyperactivity Disorder ADHD Transcranial Magnetic Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

ADHD PreSMA Response Inhibition Therapy

Quick Facts

Study Start:2024-09-03

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06325813

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Study Contact

Karlee Migneault, B.A.

CONTACT

513-803-5299

Karlee.Migneault@cchmc.org

Principal Investigator

Steve W Wu, M.D.

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Steve W Wu, M.D., PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-03

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-09-03

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

ADHD
Transcranial Magnetic Stimulation

Additional Relevant MeSH Terms

Attention Deficit Hyperactivity Disorder