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

St. Jude Children's Research Hospital

Status: Active, not recruiting

Conditions: Transcranial Direct Current Stimulation; Acute Lymphoblastic Leukemia; Executive Dysfunction

Treatments: Device: Sham treatment; Other: Grooved Peg Board Test; Device: Anodal tDCS treatment; Other: NIH Toolbox Flanker Inhibitory Control and Attention Test; Other: Buschke Selective Reminding Test; Other: NIH Toolbox List Sorting Working Memory Test; Device: Cathodal tDCS treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04105530

ALLSUP

NCI-2019-07041 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 8 years to 215 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

Transcranial direct current stimulation (tDCS) on day 1

Active Comparator group

Description:

One stimulation will be conducted using Anodal treatment. The Direct Current Anodal Stimulation will be applied for 20 minutes for each stimulation period. Brief neurocognitive testing will be conducted during each stimulation session.

Treatment:

Other: NIH Toolbox List Sorting Working Memory Test

Other: Grooved Peg Board Test

Device: Anodal tDCS treatment

Other: Buschke Selective Reminding Test

Other: NIH Toolbox Flanker Inhibitory Control and Attention Test

Transcranial direct current stimulation (tDCS) on day 2

Active Comparator group

Description:

A final stimulation will be conducted using Cathodal stimulation. Direct Current Cathodal Stimulation will be applied for 20 minutes for each stimulation period. Brief neurocognitive testing will be conducted during each stimulation session.

Treatment:

Other: NIH Toolbox List Sorting Working Memory Test

Device: Cathodal tDCS treatment

Other: Grooved Peg Board Test

Other: Buschke Selective Reminding Test

Other: NIH Toolbox Flanker Inhibitory Control and Attention Test

Sham treatment

Placebo Comparator group

Description:

The sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramping up and no intervention is provided. Sham will be applied for 20 minutes.Stimulation will start 5 minutes before testing and continue throughout completing the NIH Toolbox Cognitive Battery at each trial:"

Treatment:

Other: NIH Toolbox List Sorting Working Memory Test

Device: Sham treatment

Other: Grooved Peg Board Test

Other: Buschke Selective Reminding Test

Other: NIH Toolbox Flanker Inhibitory Control and Attention Test