Brain stimulation for teenagers with ADHD
A Trial of Two-Week Brain Stimulation for Teenagers with ADHD
This study is testing if a special brain stimulation treatment can help teenagers with ADHD improve their working memory and reduce their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Bradley Hospital Academic / other |
| Locations | 1 site (East Providence, Rhode Island) |
| Trial ID | NCT05102864 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of non-invasive brain stimulation on adolescents aged 12-18 with ADHD and working memory deficits. The study employs intermittent theta burst stimulation (iTBS) targeting the dorsolateral prefrontal cortex (DLPFC) to modulate brain dynamics associated with working memory. Participants will undergo a two-week course of active iTBS followed by a two-week course of sham stimulation in a crossover, double-blind design. The goal is to determine if iTBS can lead to lasting improvements in working memory and ADHD symptoms.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 with a clinical diagnosis of ADHD and significant working memory deficits.
Not a fit: Patients who do not have ADHD or those with IQ below 80 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for improving working memory and reducing ADHD symptoms in adolescents.
How similar studies have performed: Other studies have shown promise with non-invasive brain stimulation techniques, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Ability to provide assent and have parent provide parental permission 2. English fluency of the participant and the legal guardian/parent 3. 12-18 years 4. Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean. 5. IQ \> 80 6. Clinical diagnosis of attention deficit hyperactivity disorder (ADHD): predominantly inattentive type, predominantly hyperactive/impulsive type, combined type, or unspecified type. Diagnostic criteria will be confirmed with NICHQ Vanderbilt Assessment Scales-Parent. 7. Participants are allowed to continue clinical ADHD treatments. However, changes to ADHD treatments cannot be made during the entirety of study participation. Confirming a plan of treatment stability will occur as part of initial inclusion criteria. We will check on treatment stability at the start of each two-week phase with the participant and parent, and document accordingly. Changes to treatment will be reviewed by a physician and may result in study termination. 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 the majority 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, braces or fillings) 7. Non-removable makeup or piercings 8. Pacemaker 9. Implanted medication pump 10. Vagal nerve stimulator 11. Deep brain stimulator 12. TENS unit (unless removed completely for the study) 13. Ventriculo-peritoneal shunt 14. Signs of increased intracranial pressure 15. Intracranial lesion (including incidental finding on MRI) 16. History of head injury resulting in prolonged loss of consciousness 17. Substance abuse or dependence within past six months (i.e., DSM-5 substance use disorder criteria) 18. 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. 19. Active psychosis or mania 20. Current suicidal intent 21. Current pregnancy 22. Significant visual, hearing or speech impairment 23. Current wards of the state
Where this trial is running
East Providence, Rhode Island
- E. P. Bradley Hospital — East Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Brian C Kavanaugh, PsyD ABPP
- Email: Bkavanaugh@lifespan.org
- Phone: 4014321359
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.