N/A
N=33
Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02336282 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Feasibility of At Home tDCS Intervention — 25 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial Direct Current Stimulation (tDCS) (Device); Sham (Device); Cognitive Assessment (Other); Brain Games Stimulation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Jude Children's Research Hospital
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of At Home tDCS Intervention |
25 | — |
| SECONDARY Digit Span Forward |
5.7; 5.7 | — |
| SECONDARY Neurocognitive Questionnaire: CCSS-NCQ |
17.5; 16.2; 8.1; 8.3; 6.1; 5.7 | — |
| SECONDARY NIH Toolbox Card Sort Task |
29.2; 29.1 | — |
| SECONDARY NIH Toolbox Flanker Task |
19.9; 20.0 | — |
| SECONDARY NIH Toolbox Working Memory Function |
17.0; 16.8 | — |
| SECONDARY Digit Span Backward |
3.7; 4.2 | — |
| SECONDARY Verbal Fluency |
33.1; 34.7 | — |
| SECONDARY Oral Trail Making Part A |
9.4; 10.0 | — |
| SECONDARY Oral Trail Making Part B |
53.1; 47.2 | — |
Summary
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02336282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.