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Compares treatment options for ADHD
Official title Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD
ClinicalTrials.gov ID: NCT07219810
What this study is testing
- What it's testing
- The objective of this project is to examine the differential therapeutic effect of intermittent theta burst stimulation (iTBS; a type of repetitive transcranial magnetic stimulation) to the left DLPFC versus right PreSMA in modulating working memory (WM) versus inhibitory control (IC) deficits. Fifty adolescents (12-18 years old) with parent-reported WM and IC deficits and diagnosed ADHD will be randomized to DLPFC or PreSMA targeted 3x-daily iTBS for a total of ten days (30 total sessions).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- Age 12-18 years
- English fluency of participant and parent and able to provide informed consent/assent
- Clinical diagnosis of ADHD and confirmation of diagnostic criteria on the Diagnostic Interview for Anxiety, Mood, and OCD and Related...
- Parent rating on The Behavior Rating Inventory of Executive Function-Second Edition (BRIEF-2), Parent Form: Working Memory scale T-Score \> 60 AND...
- IQ \> 70
You likely can't join if
- Participants will be screened to exclude individuals with neurological or medical conditions that might confound the results, as well as to exclude...
- Intracranial pathology from a known genetic disorder (e.g., NF1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor)...
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
- Any progressive (e.g., neurodegenerative) neurological disorder
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation...
See the full eligibility criteria
- Age 12-18 years
- English fluency of participant and parent and able to provide informed consent/assent
- Clinical diagnosis of ADHD and confirmation of diagnostic criteria on the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders, Child and Adolescent Version (DIAMOND-KID)
- Parent rating on The Behavior Rating Inventory of Executive Function-Second Edition (BRIEF-2), Parent Form: Working Memory scale T-Score \> 60 AND Inhibition scale T-Score \> 60
- IQ \> 70
- Participants will be screened to exclude individuals with neurological or medical conditions that might confound the results, as well as to exclude participants in whom MRI or TMS might result in increased risk of side...
- Intracranial pathology from a known genetic disorder (e.g., NF1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
- History of fainting spells of unknown or undetermined etiology that might constitute seizures
- History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
- Any progressive (e.g., neurodegenerative) neurological disorder
- Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
- Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings)
- Non-removable makeup or piercings
- Pacemaker, implanted medication pump, or ventriculo-peritoneal shunt
- Vagal nerve stimulator, deep brain stimulator, or transcutaneous electrical nerve stimulation unit
- Signs of increased intracranial pressure
- Intracranial lesion
- History of head injury resulting in prolonged loss of consciousness
- Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria)
- Chronic treatment with prescription medications that decrease cortical seizure threshold, not including psychostimulant medication if deemed to be medically safe as part of the medical review process.
- Active psychosis or mania
- Acute suicidal intent
- Current pregnancy
- Significant visual, hearing or speech impairment
- Dental braces
- Current wards of the state
The study team makes the final eligibility decision.
Where it's taking place
- East Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include East Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.