Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD
NCT ID: NCT07219810
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-09-01
2029-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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iTBS to the left DLPFC
intermittent theta burst stimulation (iTBS)
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.
iTBS to the right pre-SMA
intermittent theta burst stimulation (iTBS)
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.
Interventions
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intermittent theta burst stimulation (iTBS)
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.
Eligibility Criteria
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Inclusion Criteria
2. English fluency of participant and parent and able to provide informed consent/assent
3. 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)
4. 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
5. IQ \> 70
Exclusion Criteria
2. History of fainting spells of unknown or undetermined etiology that might constitute seizures
3. History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
4. Any progressive (e.g., neurodegenerative) neurological disorder
5. Chronic (particularly) uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
6. Contraindicated metal implants in the head, brain or spinal cord (excluding dental implants or fillings)
7. Non-removable makeup or piercings
8. Pacemaker, implanted medication pump, or ventriculo-peritoneal shunt
9. Vagal nerve stimulator, deep brain stimulator, or transcutaneous electrical nerve stimulation unit
10. Signs of increased intracranial pressure
11. Intracranial lesion
12. History of head injury resulting in prolonged loss of consciousness
13. Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria)
14. 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.
15. Active psychosis or mania
16. Acute suicidal intent
17. Current pregnancy
18. Significant visual, hearing or speech impairment
19. Dental braces
20. Current wards of the state
12 Years
18 Years
ALL
No
Sponsors
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Bradley Hospital
OTHER
Responsible Party
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Locations
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E. P. Bradley Hospital
East Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2323018
Identifier Type: -
Identifier Source: org_study_id
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