- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04105530
Transcranial Direct Current Stimulation of the Temporal Cortex in Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transcranial direct current stimulation (tDCS) on day 1
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. |
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.
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.
|
Active Comparator: Transcranial direct current stimulation (tDCS) on day 2
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.
|
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.
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.
|
Placebo Comparator: 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:"
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who completed three sessions of tDC stimulation and cognitive testing.
Time Frame: 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).
|
12 months after participant enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bushke selective remining test (BSRT)
Time Frame: 48 hours
|
BSRT is a test that evaluates verbal memory performance
|
48 hours
|
NIH toolbox list sorting working memory test (WM)
Time Frame: 48 hours
|
WM is a test that evaluates information processing and storage performance
|
48 hours
|
NIH toolbox flanker inhibitory control and attention test (Flanker)
Time Frame: 48 hours
|
Flanker is a test that evaluates attention and inhibitory control
|
48 hours
|
Grooved peg board test (GPB)
Time Frame: 48 hours
|
GPB is a test that evaluates visual-motor coordination and motor speed
|
48 hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nicholas S Phillips, MD, PhD, St. Jude Children's Research Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALLSUP
- NCI-2019-07041 (Registry Identifier: NCI)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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