Status:
COMPLETED
Brain Stimulation for Working Memory Deficits in Adolescents With ADHD
Lead Sponsor:
Bradley Hospital
Collaborating Sponsors:
Thrasher Research Fund
Rhode Island Foundation
Conditions:
ADHD With Working Memory Deficits
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief Summary
Working memory (WM) is the foundational cognitive control process of holding information 'in mind' to execute goal-directed behaviors. WM deficits are an established component of ADHD. Despite being o...
Eligibility Criteria
Inclusion
- Ability to provide assent and have parent provide parental permission
- English fluency
- 13-17 years
- List Sorting Test (NIH Toolbox) performance: Greater than 1.0 standard deviation (SD) below normative mean
- Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean
- IQ \> 80
- 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
- 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 rTMS might result in increased risk of side effects or complications. Common TMS 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. This accounts for the majority of the exclusion criteria listed:
- 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)
- Pacemaker
- Implanted medication pump
- Vagal nerve stimulator
- Deep brain stimulator
- TENS unit (unless removed completely for the study)
- Ventriculo-peritoneal shunt
- Signs of increased intracranial pressure
- Intracranial lesion (including incidental finding on MRI)
- 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 met)
- Chronic treatment with prescription medications that decrease cortical seizure threshold
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03480737
Start Date
November 1 2019
End Date
March 30 2023
Last Update
September 15 2025
Active Locations (1)
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1
E. P. Bradley Hospital
East Providence, Rhode Island, United States, 02915