Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD
ConditionADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorBradley Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
intermittent theta burst stimulation (iTBS)
DeviceDevice: 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 groups
50 Participants
are divided into 2 treatment groupsGroup A: iTBS to the left DLPFCExperimental treatment 1 intervention
Group B: iTBS to the right pre-SMAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
EEG, source-localized oscillatory beta band bursting during SST/SWMT
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).
Time frame
Visit 13, approximately 1-2 days after iTBS2
fMRI-measured blood oxygenation level-dependent (BOLD) activity during SST/NBT
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).
Time frame
Visit 13, approximately 1-2 days after iTBS3
Task-based WM/IC performance on SWMT/N-Back/SST
PreSMA-targeted iTBS will lead to greater relative improvement of IC versus WM (and the opposite pattern for DLPFC-targeted iTBS)
Time frame
Visit 13, approximately 1-2 days after iTBS4
Rater-Based WM/IC symptoms (BRIEF-2)
PreSMA-targeted iTBS will lead to greater relative improvement of IC versus WM (and the opposite pattern for DLPFC-targeted iTBS)
Time frame
Visit 13, approximately 1-2 days after iTBSSponsors and contacts
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Source ClinicalTrials.gov