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NCT05662280
NIMH K23: Modulation of Frontoparietal Dynamics in Adolescent Working Memory Deficits
Conditions: Working Memory
Sex: All
Ages: 13 Years – 18 Years
Phase: NA
Enrollment: 40
Sponsor: Bradley Hospital
Location: United States
Summary
Working memory (WM) deficits are a transdiagnostic feature of adolescent psychopathology that substantially contribute to poor clinical and functional outcomes.
This proposal will utilize a multimodal neuroscientific approach to investigate whether non-invasive brain stimulation can modulate the neural mechanisms underlying adolescent WM deficits.
Directly in line with NIMH priorities, the researchers will identify the contributing roles of prefrontal and parietal regions in WM processes, as well as identify optimal targets and parameters for novel brain-based treatments in adolescent psychopathology.
This study is funded by the NIMH-K23
Eligibility Criteria
We will enroll a sample of adolescents (age 13-17 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 CriteriaAbility to provide assent and have parent provide parental permissionEnglish fluency of the participant and the legal guardian/parent13-17 yearsParent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean.IQ > 80Clinical 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: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 dysmorphologyHistory of fainting spells of unknown or undetermined etiology that might constitute seizuresHistory of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsyAny progressive (e.g., neurodegenerative) neurological disorderChronic (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, braces or fillings)Non-removable makeup or piercingsPacemakerImplanted medication pumpVagal nerve stimulatorDeep brain stimulatorTENS unit (unless removed completely for the study)Ventriculo-peritoneal shuntSigns of increased intracranial pressureIntracranial lesion (including incidental finding on MRI)History of head injury resulting in prolonged loss of consciousnessSubstance 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 maniaCurrent suicidal intentCurrent pregnancySignificant visual, hearing or speech impairmentCurrent wards of the state
Source: ClinicalTrials.gov (NCT05662280). StuddyBuddy aggregates publicly available trial information.