Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
- Conditions
- Acute Lymphoblastic LeukemiaTranscranial Direct Current StimulationExecutive Dysfunction
- Interventions
- Device: Cathodal tDCS treatmentDevice: Sham treatmentDevice: Anodal tDCS treatmentOther: NIH Toolbox List Sorting Working Memory TestOther: NIH Toolbox Flanker Inhibitory Control and Attention TestOther: Grooved Peg Board TestOther: Buschke Selective Reminding Test
- Registration Number
- NCT04105530
- Lead Sponsor
- St. Jude Children's Research Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Transcranial direct current stimulation (tDCS) on day 1 NIH Toolbox Flanker Inhibitory Control and Attention Test 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. Transcranial direct current stimulation (tDCS) on day 2 Grooved Peg Board Test 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. Transcranial direct current stimulation (tDCS) on day 1 NIH Toolbox List Sorting Working Memory Test 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. Transcranial direct current stimulation (tDCS) on day 1 Buschke Selective Reminding Test 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. Transcranial direct current stimulation (tDCS) on day 2 Cathodal tDCS treatment 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. Transcranial direct current stimulation (tDCS) on day 2 NIH Toolbox List Sorting Working Memory Test 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. Sham treatment Sham treatment 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:" Sham treatment Grooved Peg Board Test 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:" Transcranial direct current stimulation (tDCS) on day 1 Anodal tDCS treatment 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. Transcranial direct current stimulation (tDCS) on day 1 Grooved Peg Board Test 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. Transcranial direct current stimulation (tDCS) on day 2 NIH Toolbox Flanker Inhibitory Control and Attention Test 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. Sham treatment NIH Toolbox Flanker Inhibitory Control and Attention Test 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:" Transcranial direct current stimulation (tDCS) on day 2 Buschke Selective Reminding Test 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. Sham treatment NIH Toolbox List Sorting Working Memory Test 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:" Sham treatment Buschke Selective Reminding Test 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:"
- Primary Outcome Measures
Name Time Method Number of participants who completed three sessions of tDC stimulation and cognitive testing. 12 months after participant enrollment The trial will be considered feasible if at least 30 survivors are able to complete 3 sessions (tDCS along with cognitive testing).
- Secondary Outcome Measures
Name Time Method Grooved peg board test (GPB) 48 hours GPB is a test that evaluates visual-motor coordination and motor speed
Bushke selective remining test (BSRT) 48 hours BSRT is a test that evaluates verbal memory performance
NIH toolbox flanker inhibitory control and attention test (Flanker) 48 hours Flanker is a test that evaluates attention and inhibitory control
NIH toolbox list sorting working memory test (WM) 48 hours WM is a test that evaluates information processing and storage performance
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States