CompletedNot Applicable

Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

United States127 participantsStarted 2019-12-12

Plain-language 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. 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 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.

Who can participate

Age range

18 Years – 39 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Direct Testing of Executive Function: Change in Working Memory from baseline to 6 months

Timeframe: Baseline & 6-month follow-up

Direct Testing of Executive Function: Change in Cognitive Flexibility in baseline to 6 months

Timeframe: Baseline & 6-month follow-up

Direct Testing of Executive Function: Change in Verbal Fluency from baseline to 6 months

Timeframe: Baseline & 6-month follow-up

Trial details

NCT IDNCT04007601

SponsorSt. Jude Children's Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-21

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials

Plain-language summary

Who can participate

Age range

18 Years – 39 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Direct Testing of Executive Function: Change in Working Memory from baseline to 6 months

Timeframe: Baseline & 6-month follow-up

Direct Testing of Executive Function: Change in Cognitive Flexibility in baseline to 6 months

Timeframe: Baseline & 6-month follow-up

Direct Testing of Executive Function: Change in Verbal Fluency from baseline to 6 months

Timeframe: Baseline & 6-month follow-up