Modulating brain activity to improve working memory in adolescents
NIMH K23: Modulation of Frontoparietal Dynamics in Adolescent Working Memory Deficits
This study is testing if a new brain stimulation technique can help improve working memory in teenagers with ADHD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Bradley Hospital Academic / other |
| Locations | 1 site (East Providence, Rhode Island) |
| Trial ID | NCT05662280 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of non-invasive brain stimulation to enhance working memory in adolescents with deficits, particularly those diagnosed with ADHD. By employing a multimodal neuroscientific approach, researchers aim to understand the roles of the prefrontal and parietal brain regions in working memory processes. The study will utilize intermittent theta burst stimulation (iTBS) to modulate neural dynamics and assess its effects on working memory performance. Participants will be adolescents aged 12-18 who meet specific criteria related to working memory deficits and ADHD.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 12-18 with diagnosed working memory deficits and ADHD.
Not a fit: Patients without working memory deficits or those not diagnosed with ADHD may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new brain-based treatments that significantly improve working memory in adolescents, enhancing their clinical and functional outcomes.
How similar studies have performed: While the approach of using non-invasive brain stimulation for cognitive enhancement is gaining traction, this specific application in adolescents with working memory deficits is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Researchers will enroll a sample of adolescents (age 12-18 years) with working memory deficits and ADHD. Participation in this study will not require any adjustments to their clinical care. There are no costs to this study (participants compensated) and there are no expected long-term benefits to the participants. Participants will be compensated for each session. Participants can withdraw from the study at any time. 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. 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 Kavanaugh, PsyD ABPP
- Email: Brian_Kavanaugh@Brown.edu
- Phone: 14014321359
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.