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Recruiting NCT07219810

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

No phase Interventional ADHD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intermittent theta burst stimulation (iTBS).
Who it may be relevant to
Registry conditions: ADHD. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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).

Interventions

  • Device 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-

Primary outcome measures

  • EEG, source-localized oscillatory beta band bursting during SST/SWMT [Time frame: Visit 13, approximately 1-2 days after iTBS]
  • fMRI-measured blood oxygenation level-dependent (BOLD) activity during SST/NBT [Time frame: Visit 13, approximately 1-2 days after iTBS]
  • Task-based WM/IC performance on SWMT/N-Back/SST [Time frame: Visit 13, approximately 1-2 days after iTBS]
  • Rater-Based WM/IC symptoms (BRIEF-2) [Time frame: Visit 13, approximately 1-2 days after iTBS]

Eligibility criteria

Inclusion 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

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:

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • E. P. Bradley Hospital — East Providence

Identifiers

NCT: NCT07219810 · 2323018

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗