Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

  • STATUS
    Recruiting
  • days left to enroll
    29
  • participants needed
    30
  • sponsor
    St. Jude Children's Research Hospital
Updated on 24 October 2022
cancer
stroke
lymphoid leukemia
childhood all

Summary

Brief Overview: Children and adolescents diagnosed with cancer will experience problems with learning, memory and attention during and after completing their cancer therapy. There are many factors that contribute to this problem, but investigators have recently identified that chemotherapy agents used in treating Acute Lymphoblastic Leukemia (ALL) may disrupt normal brain development.

A novel device has been developed that may help correct this disruption. Direct Current Stimulation (DCS) uses a very low level of constant electrical current to stimulate specific parts of the brain. It has been used in patients with stroke to great benefit. Our study at St. Jude Children's Research Hospital is designed to see if this technique will benefit survivors of childhood cancer. Specifically, investigators wish to see if stimulating one part of the brain gives a greater benefit than stimulating another part of the brain.

Primary Objective

Evaluate the feasibility of conducting repeated on-site Transcranial Direct Current Stimulation (tDCS) in children who are long-term survivors of

Secondary Objectives

  • To estimate the potential efficacy for powering a future larger study using tDCS to improve cognitive performance in children by suppressing over connected neural hubs in long-term survivors of childhood ALL.
  • To compare the performance of anodal stimulation of the frontal lobe to cathodal suppression of the superior temporal lobe on cognitive performance.

Description

Participants will be randomly assigned to one of three intervention arms. Two brief stimulation periods will be conducted on day one. One brief stimulation will be scheduled in the morning and a second brief stimulation will be scheduled in the afternoon. A final stimulation will be conducted on day two. Direct Current Stimulation will be applied for 20 minutes for each stimulation period. Brief neurocognitive testing will be conducted during each stimulation session.

Details
Condition Acute Lymphoblastic Leukemia, Transcranial Direct Current Stimulation, Executive Dysfunction
Treatment Sham Treatment, Anodal tDCS treatment, Cathodal tDCS treatment, NIH Toolbox List Sorting Working Memory Test, NIH Toolbox Flanker Inhibitory Control and Attention Test, Grooved Peg Board Test, Buschke Selective Reminding Test
Clinical Study IdentifierNCT04105530
SponsorSt. Jude Children's Research Hospital
Last Modified on24 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

ALL survivors who received chemotherapy-only treatment and are enrolled in SJLIFE
-17 years old
History of executive function, processing speed and/or memory impairment documented as a score < 10th percentile of the age adjusted Z-score
Participants able to speak and understand the English language

Exclusion Criteria

Survivors who received cranial radiation
Survivors with a Full-Scale IQ < 70\
Pregnant, history of migraines, epilepsy or traumatic brain injury
Have a scalp or skin condition (e.g., psoriasis or eczema), metallic implants (except for dental fillings or caps) or retained metal fragments
History of neurologic condition or genetic disorder associated with neurocognitive impairment unrelated to cancer diagnosis or treatment
Not fluent in English
Taking a psychoactive drug or stimulant
Clear my responses

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