Acute Lymphoblastic LeukemiaNCT04007601
Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
A study testing Active tDCS in people with Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Long-term survivors of ALL are at-risk for neurocognitive impairment, particularly in the area of executive functioning. Relatively limited research has focused on interventions for improving neurocognitive outcomes in long-term survivors of ALL. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2019to 21 Jun 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Completed treatment for acute lymphoblastic leukemia (ALL) at SJCRH < 21 years at diagnosis
- Enrolled on St. Jude Lifetime Cohort Study
- ≥ 5 years post-diagnosis of ALL
- ≥ 2 years post-treatment completion deemed to impact the central nervous system.
- Currently between 18 and 39 years of age
- English language proficiency
- Executive dysfunction defined as having an age-adjusted standard score <16th percentile on Trail Making Test Part B, Controlled Oral Word association Test, or Digit Span Backward
- Patient-reported executive dysfunction defined as a standard score >84th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire or the Behavior Rating Scale of Executive Function
Who cannot join
- Full scale intelligence score <80
- Currently taking medication intended to treat neurocognitive impairment (e.g. stimulants)
- Participated in a past trial of neurostimulation
- Female who is pregnant or breastfeeding
- History of seizures within the past year
- Implanted medical devices or metal in the head
- History of head injury or a neurodevelopmental disorder (i.e. genetic disorder, hypoxic-ischemic encephalopathy) associated with neurocognitive impairment and unrelated to cancer treatment
- Currently receiving cancer directed therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Long-term survivors of ALL are at-risk for neurocognitive impairment, particularly in the area of executive functioning. Relatively limited research has focused on interventions for improving neurocognitive outcomes in long-term survivors of ALL. A promising technique for cognitive enhancement is Transcranial Direct Current Stimulation (tDCS) which differs from conventional cognitive remediation approaches in that it directly stimulates specific brain regions responsible for cognitive processes and activates functional networks similar to those activated during cognitive training.
Primary Objective
Read more
To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on direct testing of executive function in survivors of ALL.
Secondary Objectives
- To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on patient-reported symptoms of executive dysfunction in survivors of ALL.
- To examine the effects of home-based tDCS paired with remote cognitive training on patterns of regional brain activation as measured by functional magnetic resonance imaging.
- To examine the effects of home-based tDCS paired with remote cognitive training on white matter integrity and structure as measured by diffusion tensor imaging.
Read the detailed description
Eligible participants will be randomized to receive 1 mA direct current stimulation over the left dorsolateral prefrontal cortex or placebo/sham for 20 minutes. All participants will receive home-based computerized cognitive training. Participants will complete tDCS paired with cognitive training 2 times per week for 6-months.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Acute Lymphoblastic Leukemia, Neurocognitive impairment, Executive dysfunction, Survivorship
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Participants will receive active 1mA direct current stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.
Sham tDCSDevice
Participants will receive sham (no direct current) stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Remotely delivered active tDCS + cognitive training Receives: Device: Active tDCS |
| Sham tDCS | Placebo comparator | Remotely delivered sham tDCS + cognitive training Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct Testing of Executive Function: Change in Working Memory From Baseline to 6 Months
Efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on neurocognitive functioning in long- term survivors of ALL. The measures were analyzed to compare changes in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and a standard deviation of 1. A higher z-score represents a better outcome.
Digit Span Backward: Digit Span Backward (DSB), from the Digit Span subtest on the WAIS-IV, is a measure of working memory. The number of digits recalled in the longest span is converted to a standard z-score using age-based norms (Mean=0, SD=1). A higher z-score represents a better outcome.
Measured: Baseline & 6-month follow-up
Direct Testing of Executive Function: Change in Cognitive Flexibility in Baseline to 6 Months
Efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on neurocognitive functioning in long- term survivors of ALL. The measures were analyzed to compare changes in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and a standard deviation of 1. A higher z-score represents a better outcome.
Trail Making Test Part B (Trails B): This is a timed task that requires a participant to shift his/her attention adaptively and flexibly. Age-based standardized z-scores are calculated (Mean=0, SD=1). A higher z-score represents a better outcome.
Measured: Baseline & 6-month follow-up
Direct Testing of Executive Function: Change in Verbal Fluency From Baseline to 6 Months
Efficacy of home-based transcranial direct current stimulation (tDCS) paired with remote cognitive training on neurocognitive functioning in long- term survivors of ALL. The measures were analyzed to compare changes in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and a standard deviation of 1. A higher z-score represents a better outcome.
Controlled Oral Word Association (COWA): This is a task of cognitive/verbal fluency that measures spontaneous production of words beginning with a designated letter or category. Age-based standardized z-scores are calculated (Mean=0, SD=1). A higher z-score represents a better outcome.
Measured: Baseline & 6-month follow-up
Secondary outcomes (5)
Change in Patient-Reported Symptoms of Executive Functioning From Baseline to 6 Months
Patient reported symptoms of executive dysfunction will be evaluated via the Childhood Cancer Survivor Study Neurocognitive Questionnaire (CCSS-NCQ). The CCSS-NCQ is a 32-item questionnaire evaluating 4 domains of executive function. Z-scores (M=0, SD=1) are calculated using sibling data from the Childhood Cancer Survivor Study. Z-scores apply to all outcome rows (task efficiency, memory, organization, emotion regulation). A higher z-scores represents a better outcome.
Measured: Baseline and 6-month follow-up
Change in Patient-Reported Symptoms of Executive Functioning From Baseline to 6 Months
Patient reported symptoms of executive dysfunction will be evaluated via the Behavior Rating Inventory for Executive Function - Adult Version (BRIEF-A). The BRIEF-A is a 75-item measure of executive function that provides age- and sex-specific national normative data for nine domains of executive function Z-scores (M=0, SD=1) are reported. A higher z-score represents a better outcome.
Measured: Baseline and 6-month follow-up
Change in Structural Brain Connectivity From Baseline to 6 Months
Structural brain networks are constructed from pair-wise white matter connections between brain regions from diffusion tensor imaging. Streamline density is a normalized (values between 0 and 1), unitless measure that characterizes the amount of white matter connectivity between 2 regions of interest. Higher streamline densities suggest a stronger, more robust structural connection. Here, a positive or negative change in streamline density indicates strengthening or weakening connectivity, respectively.
Measured: Baseline and 6-month follow-up
Change in Functional Brain Connectivity From Baseline to 6 Months
Functional brain networks are constructed from pair-wise correlation of activity in brain regions during resting state functional-MRI. Global efficiency, local efficiency, and clustering coefficient are normalized graph metrics (values between 0 and 1) that characterize brain networks and follow an inverted U-shape. Tendency towards either extreme is associated with disrupted cognitive function. Global and local efficiency are measures of parallel information transfer across the whole brain network and smaller subnetworks respectively. Lower values denote less capacity for parallel information transfer than higher values. Clustering coefficient quantifies the tendency of a network to segregate into neighborhoods. Higher values denote higher segregation.
Measured: Baseline and 6-month follow-up
Parameter Estimate (Beta Weight) of Left DLPFC During an N-Back Task From Baseline to 6 Months
Functional magnetic resonance imaging (fMRI) was used to measure local hemodynamics in a pre-defined region of interest (ROI) in the left dorsolateral prefrontal cortex (Left DLPFC). Individual task-related brain activity was modeled using a General Linear Model (GLM). Reported values represent the group mean parameter estimate (beta weight) extracted from the Left DLPFC ROI for the 2-back (working memory) condition relative to the 0-back (baseline) condition of an N-back task. A higher parameter estimate indicates greater relative neural activation during the working memory condition.
Measured: Baseline & 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start12 Dec 2019
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Tara Brinkman, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007601
- Sponsor's protocol ID
- NEUROSTIM
- Other IDs
- R01CA239630
- Status last verified
- Oct 2026
- First submitted
- 18 Jun 2019
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes