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Completed
NCT04007601
Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
Conditions: Acute Lymphoblastic Leukemia
Sex: All
Ages: 18 Years – 39 Years
Healthy volunteers: No
Phase: NA
Enrollment: 127
Sponsor: St. Jude Children's Research Hospital
Location: St. Jude Children's Research Hospital Memphis Tennessee
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.
Eligibility Criteria
Inclusion Criteria:
* Completed treatment for acute lymphoblastic leukemia (ALL) at SJCRH \< 21 years at diagnosis
* Enrolled on St. Jude Lifetime Cohort Study
* ≥ 5 years post-diagnosis of ALL
* ≥ 2 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 \84th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire or the Behavior Rating Scale of Executive Function
Exclusion Criteria:
* Full scale intelligence score \
Source: ClinicalTrials.gov (NCT04007601). StuddyBuddy aggregates publicly available trial information.