Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD
ID: NCT07219810
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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).
Device: Stimulation will be delivered using a Nexstim NBT System 2 device. Motor Threshold: The iTBS pulse intensity will be set at 80% of resting motor threshold (MT). The iTBS protocol will administer 2-second trains with an 8-second inter-burst interval for 1800 pulses \[600 bursts\]), in 50 Hz bursts at 5 Hz (i.e., 200 ms intervals). Each session will last approximately nine minutes. As three sessions will be administered per day, there will be a 20-30 minutes break between each of the nine-minute iTBS sessions. Magnetic pulses will be delivered in an MRI neuro-navigated manner using a cooled figure-eight coil. The PreSMA target will be approximately defined based on MNI coordinates: 13, 18, 62. The left DLPFC target will be approximately defined based on MNI coordinates: -44, 28, 16.
Treatment Arms Description
- 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
- 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
Primary Outcome Measures
- EEG, source-localized oscillatory beta band bursting during SST/SWMT — Time Frame: Visit 13, approximately 1-2 days after iTBS
PreSMA-targeted iTBS will lead to greater relative activation of the IC network versus the WM network (and the opposite pattern for DLPFC-targeted iTBS).
- fMRI-measured blood oxygenation level-dependent (BOLD) activity during SST/NBT — Time Frame: Visit 13, approximately 1-2 days after iTBS
PreSMA-targeted iTBS will lead to greater relative activation of the IC network versus the WM network (and the opposite pattern for DLPFC-targeted iTBS).
- Task-based WM/IC performance on SWMT/N-Back/SST — Time Frame: Visit 13, approximately 1-2 days after iTBS
PreSMA-targeted iTBS will lead to greater relative improvement of IC versus WM (and the opposite pattern for DLPFC-targeted iTBS)
- Rater-Based WM/IC symptoms (BRIEF-2) — Time Frame: Visit 13, approximately 1-2 days after iTBS
PreSMA-targeted iTBS will lead to greater relative improvement of IC versus WM (and the opposite pattern for DLPFC-targeted iTBS)
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
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View Official Medical/Scientific Title
Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD