Clinical trial NCT04105530: Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
Official title: Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Transcranial Direct Current Stimulation
Executive Dysfunction
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 215
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Enrollment is on hold per institutional COVID-19 guidelines
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* ALL survivors who received chemotherapy-only treatment and are enrolled in SJLIFE.
* 8-17 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.

Primary outcomes:
measure: Number of participants who completed three sessions of tDC stimulation and cognitive testing.
timeFrame: 12 months after participant enrollment
Secondary outcomes:
measure: Bushke selective remining test (BSRT)
timeFrame: 48 hours
measure: NIH toolbox list sorting working memory test (WM)
timeFrame: 48 hours
measure: NIH toolbox flanker inhibitory control and attention test (Flanker)
timeFrame: 48 hours
measure: Grooved peg board test (GPB)
timeFrame: 48 hours
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Nicholas S Phillips, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: