Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
2 other identifiers
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2019
CompletedFirst Posted
Study publicly available on registry
September 26, 2019
CompletedStudy Start
First participant enrolled
November 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedJanuary 12, 2024
January 1, 2024
4.1 years
June 25, 2019
January 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants who completed three sessions of tDC stimulation and cognitive testing.
The trial will be considered feasible if at least 30 survivors are able to complete 3 sessions (tDCS along with cognitive testing).
12 months after participant enrollment
Secondary Outcomes (4)
Bushke selective remining test (BSRT)
48 hours
NIH toolbox list sorting working memory test (WM)
48 hours
NIH toolbox flanker inhibitory control and attention test (Flanker)
48 hours
Grooved peg board test (GPB)
48 hours
Study Arms (3)
Transcranial direct current stimulation (tDCS) on day 1
ACTIVE COMPARATOROne 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
ACTIVE COMPARATORA 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
PLACEBO COMPARATORThe 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:"
Interventions
The Anodal intervention excites neuronal activity. For condition one, the anode will be attached to the left frontal region (Fp1) and the cathode will be attached to the right neck. The intervention involves a direct current of 1 mA applied for 20 minutes.
The Cathodal intervention inhibits or reduces neuronal activity. We propose that the use of the cathodal tDCS to the superior temporal gyrus in survivors of childhood ALL may facilitate the inhibition of over connected motor-sensory and auditory neural networks. For condition two, the cathode will be attached to the left temporal region (T3) and the anode will be attached to the right neck. The intervention involves a direct current of 1 mA applied for 20 minutes.
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.
List Sorting is using information processing and storage. Performance tends to peak in early adulthood and then decline across the life span. This task assesses working memory and requires the participant to sequence different visually- and orally-presented stimuli. The list scoring task takes approximately 7 minutes to administer. List Sorting is scored by summing the total number of items correctly recalled and sequenced on Lists-1 and -2, which can range from 0-26.
The Flanker tests inhibitory control and attention and the capacity for new learning and information processing novel situations. This performance also reaches a peak in early adulthood and tends to decline across the life span. A total of 40 trials require 4 minutes. Scoring is based on both accuracy and reaction time, which will we evaluate individually as well as in combination. The raw scores are converted to a scale score with a mean of 100 and SD of 15. Higher scores indicate higher executive function.
The Grooved Peg Board test measures visual-motor coordination and motor speed. Additionally, it is cognitively challenging and has been associated with attention, perceptual speed and non-verbal reasoning. Performance is better in the dominant/preferred hand and tends to improve in childhood and decline with advancing age. The test consists of placing metal pegs with ridges along onside in matching slots as quickly as possible. The score is the time in seconds required to compete the array with each hand. Longer times reflect worse performance. Times are compared to normative data that is organized by ethnicity, age, gender and education. The test takes approximately 5 minutes to complete.
This selective reminding task purports to distinguish verbal memory into short-term and long-term components. Scores are organized by short- and long-term storage and retrieval with normative scores organized by age and gender. The task requires participants to remember a list of orally-presented words and recall them with selective reminders of the words that they didn't recall. The test will last 5-10 minutes and is available in four different versions, thus reducing rehearsal effects.
Eligibility Criteria
You may qualify if:
- ALL survivors who received chemotherapy-only treatment and are enrolled in SJLIFE.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicholas S Phillips, MD, PhD
St. Jude Children's Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2019
First Posted
September 26, 2019
Study Start
November 18, 2019
Primary Completion
December 31, 2023
Study Completion
September 1, 2024
Last Updated
January 12, 2024
Record last verified: 2024-01