Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    104
  • sponsor
    St. Jude Children's Research Hospital
Updated on 17 February 2022
cancer
lymphoid leukemia
childhood all

Summary

Long-term survivors of ALL are at-risk for neurocognitive impairment, particularly in the area of executive functioning. Relatively limited research has focused on interventions for improving neurocognitive outcomes in long-term survivors of ALL. A promising technique for cognitive enhancement is Transcranial Direct Current Stimulation (tDCS) which differs from conventional cognitive remediation approaches in that it directly stimulates specific brain regions responsible for cognitive processes and activates functional networks similar to those activated during cognitive training.

Primary Objective

To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on direct testing of executive function in survivors of ALL.

Secondary Objectives

  • To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on patient-reported symptoms of executive dysfunction in survivors of ALL.
  • To examine the effects of home-based tDCS paired with remote cognitive training on patterns of regional brain activation as measured by functional magnetic resonance imaging.
  • To examine the effects of home-based tDCS paired with remote cognitive training on white matter integrity and structure as measured by diffusion tensor imaging.

Description

Eligible participants will be randomized to receive 1 mA direct current stimulation over the left dorsolateral prefrontal cortex or placebo/sham for 20 minutes. All participants will receive home-based computerized cognitive training. Participants will complete tDCS paired with cognitive training 2 times per week for 6-months.

Details
Condition Acute Lymphoblastic Leukemia
Treatment active tDCS, Sham tDCS
Clinical Study IdentifierNCT04007601
SponsorSt. Jude Children's Research Hospital
Last Modified on17 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Completed treatment for acute lymphoblastic leukemia (ALL) at SJCRH < 21 years at diagnosis
Enrolled on St. Jude Lifetime Cohort Study
years post-diagnosis of ALL
years post-treatment completion deemed to impact the central nervous system
Currently between 18 and 39 years of age
English language proficiency
Executive dysfunction defined as having an age-adjusted standard score <16th percentile on Trail Making Test Part B, Controlled Oral Word association Test, or Digit Span Backward
Patient-reported executive dysfunction defined as a standard score >84th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire or the Behavior Rating Scale of Executive Function

Exclusion Criteria

Full scale intelligence score <80
Currently taking medication intended to treat neurocognitive impairment (e.g. stimulants)
Participated in a past trial of neurostimulation
Female who is pregnant or breastfeeding
History of seizures within the past year
Implanted medical devices or metal in the head
History of head injury or a neurodevelopmental disorder (i.e. genetic disorder, hypoxic-ischemic encephalopathy) associated with neurocognitive impairment and unrelated to cancer treatment
Currently receiving cancer directed therapy
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