Clinical trial · Interventional
Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
Feasibility and Efficacy of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A common and potentially debilitating late effect of childhood cancer treatment is neurocognitive impairment, frequently in the domain of executive dysfunction, which can limit educational attainment, employment, and quality of life. Among the survivors of childhood acute lymphoblastic leukemia (ALL) in the SJLIFE cohort, the frequency of executive function impairment has been shown as high as 58.8%, with moderate to severe impairment as high as 33.5%, and risk for impairment increased with time from diagnosis. Given the potential of pervasive impact of neurocognitive impairment on daily life, interventions directed at reducing neurocognitive dysfunction among childhood cancer survivors with long-term follow-up are needed. This study examines the potential feasibility and efficacy of a novel intervention to improve executive function. Primary Objectives: * To evaluate the feasibility of a home-based intervention using Transcranial Direct Current Stimulation (tDCS) and cognitive training in adult survivors of childhood ALL participating in the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH). Secondary Objectives: * To estimate the efficacy of a tDCS intervention paired with cognitive training. * To explore the short-term effect of tDCS on measures of executive function among adult survivors of childhood ALL participating in the SJLIFE protocol
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain Games Stimulation | Other | — | UNRESOLVED |
| Cognitive Assessment | Other | — | UNRESOLVED |
| Sham | Device | — | UNRESOLVED |
| transcranial Direct Current Stimulation (tDCS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- tDCS on Day 1
- description
- On day one, participants will be randomized to receive the transcranial Direct Current Stimulation (tDCS) intervention. On day two, participants receive sham intervention. On both days 1 and 2, within two hours of completing the intervention, participants will complete cognitive assessment. In the second phase of the trial, participants will be evaluated over 5 weeks using a mobile tDCS device and Brain Games Stimulation twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. Cognitive assessment will be conducted pre- and post-intervention using remote assessment.
- interventionNames
- Device: transcranial Direct Current Stimulation (tDCS)
- Device: Sham
- Other: Cognitive Assessment
- Other: Brain Games Stimulation
- type
- ACTIVE_COMPARATOR
- label
- tDCS on Day 2
- description
- On day one, participants will be randomized to receive sham intervention. On day two, participants receive the transcranial Direct Current Stimulation (tDCS) intervention. On both days 1 and 2, within two hours of completing the intervention, participants will complete cognitive assessment. The second phase of the trial will be conducted the same as for participants in the tDCS on Day 1 arm. Participants will be evaluated over 5 weeks using a mobile tDCS device and Brain Games Stimulation twice per week. Within two hours of completing each tDCS session, participants will complete 20 minutes of cognitive training using a mobile application installed on an iPad. Cognitive testing will be conducted pre- and post-intervention using remote assessment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Current St. Jude LIFE (SJLIFE) Protocol Participant * Long term survivor of acute lymphoblastic leukemia (ALL) * Currently ≥ 18 years of age * Wi-Fi internet access at home * History of executive dysfunction, documented by neurocognitive testing, and defined as having an age-adjusted standard score \<20th percentile on Trail Making Test Part B, Verbal Fluency, or Digit Span Backward. * History of self-reported executive dysfunction in daily life, defined as having a standardized score \<20th percentile on BRIEF Initiate, Shift, or Working Memory domains OR having scored \<20th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire Task Efficiency or Memory domains. * Participant is able to speak and understand the English language. Exclusion Criteria: * Any survivor with full scale intelligence quotient (IQ) \<80 * Currently on stimulants or other medications intended to treat cognitive impairment * History of seizures * No implanted medical devices or implanted metal in the head * Currently pregnant or planning to become pregnant. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
References
Publications (0)
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