Accelerated iTBS Targeting of Working Memory Versus Inhibitory Control in Adolescent ADHD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- EEG, source-localized oscillatory beta band bursting during SST/SWMT
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
EEG, source-localized oscillatory beta band bursting during SST/SWMT
时间窗: 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
时间窗: 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)
fMRI-measured blood oxygenation level-dependent (BOLD) activity during SST/NBT
时间窗: 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).
Rater-Based WM/IC symptoms (BRIEF-2)
时间窗: 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)
次要结局
未报告次要终点