rTMS and EF Training for Working Memory Deficits in Adolescent Psychopathology

  • STATUS
    Recruiting
  • days left to enroll
    68
  • participants needed
    25
  • sponsor
    Bradley Hospital
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Updated on 18 November 2019
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Summary

Executive functioning (EF) deficits are a core, transdiagnostic feature of psychopathology and one of the strongest predictors of clinical and functional outcomes, yet there remains a dearth of treatments available for EF deficits. EF is a collection of cognitive control processes that includes working memory (i.e., maintain/manipulate data not perceptually present), inhibition (i.e., inhibit/control of attention, thoughts, behaviors) and flexibility (i.e., shift flexibly between tasks/sets). These EF subdomains are subserved by a network (i.e., cognitive control network) of frontal (e.g., dorsolateral prefrontal cortex [DLPFC]), parietal and subcortical regions, with hypoactivation in such regions often underlying EF deficits. There is a recent call in psychiatry to develop experimental therapeutics that target anomalous neural systems underlying symptomology. Repetitive transcranial magnetic stimulation (rTMS) is a therapeutic, non-invasive method of cortical excitability modulation. High frequency rTMS to the left DPLFC has an activating effect on the cognitive control network, with initial research in adults finding a subsequent enhancing effect on working memory, inhibition, and flexibility. rTMS represents a very promising potential tool to target EF deficits in psychopathology.

Details
Treatment Magstim Super Rapid2 stimulator, 10 Hz condition, Magstim Super Rapid2 stimulator, Sham condition, Magstim Super Rapid2 stimulator, iTBS condition
Clinical Study IdentifierNCT03480737
SponsorBradley Hospital
Last Modified on18 November 2019

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Eligibility

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Inclusion Criteria

Is your age between 13 yrs and 17 yrs?
Gender: Male or Female
Do you have ADHD With Working Memory Deficits?
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 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 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
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