Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD (WINK)

Bradley Hospital

Status: Enrolling

Conditions: ADHD

Treatments: Device: intermittent theta burst stimulation (iTBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07219810

2323018

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Age 12-18 years
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

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 effects or complications. Common contraindications include metallic hardware in the body, cardiac pacemaker, patients with an implanted medication pumps or an intracardiac line, or prescription of medications known to lower seizure threshold. These account for most of the exclusion criteria listed below:

1. 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
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

iTBS to the left DLPFC

Experimental group

Treatment:

Device: intermittent theta burst stimulation (iTBS)

iTBS to the right pre-SMA

Active Comparator group

Treatment:

Device: intermittent theta burst stimulation (iTBS)