RecruitingNot ApplicableNCT05662280

NIMH K23: Modulation of Frontoparietal Dynamics in Adolescent Working Memory Deficits


Sponsor

Bradley Hospital

Enrollment

40 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 18 Years

Inclusion Criteria7

  • 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.
  • Ability to provide assent and have parent provide parental permission
  • English fluency of the participant and the legal guardian/parent
  • 12-18 years
  • 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 Criteria23

  • 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, braces or fillings)
  • Non-removable makeup or piercings
  • 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)
  • 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
  • Current suicidal intent
  • Current pregnancy
  • Significant visual, hearing or speech impairment
  • Current wards of the state

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Interventions

DEVICEActive Intermittent Theta Burst Stimulation

Standard iTBS protocol with active coil

DEVICESham Intermittent Theta Burst Stimulation

Standard iTBS protocol with active coil


Locations(1)

E. P. Bradley Hospital

East Providence, Rhode Island, United States

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NCT05662280


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