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
2 other identifiers
interventional
53
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2014
CompletedFirst Posted
Study publicly available on registry
January 12, 2015
CompletedStudy Start
First participant enrolled
January 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2017
CompletedResults Posted
Study results publicly available
August 24, 2018
CompletedSeptember 18, 2023
August 1, 2023
2.5 years
December 18, 2014
April 5, 2018
August 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of At Home tDCS Intervention
This outcome measures the feasibility of remote tDCS and cognitive training. The trial will be considered feasible if at least 50% of the survivors are able to complete 5 sessions (tDCS along with cognitive stimulation) successfully out of 10.
5 weeks after participant enrollment
Secondary Outcomes (9)
Digit Span Forward
Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
Neurocognitive Questionnaire: CCSS-NCQ
Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.
NIH Toolbox Card Sort Task
After active and sham interventions administered on day one and day two of the trial
NIH Toolbox Flanker Task
After active and sham interventions administered on day one and day two of the trial
NIH Toolbox Working Memory Function
After active and sham interventions administered on day one and day two of the trial
- +4 more secondary outcomes
Study Arms (2)
tDCS on Day 1
ACTIVE COMPARATOROn 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.
tDCS on Day 2
ACTIVE COMPARATOROn 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.
Interventions
transcranial Direct Current Stimulation (tDCS) involves modulation of cerebral cortex excitability by the application of weak direct current to the scalp. tDCS is a technique that applies safe, low level direct current through large pads on the scalp to stimulate the underlying brain region, with current level \< 0.10 C/cm2. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode.
The sham intervention will be used in both arms with one arm receiving the sham intervention on day 1 and the other receiving the sham intervention on day 2. The sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramp up and no intervention is provided. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode.
Three tests will be used to evaluate cognitive function: Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, and List Sorting Working Memory Test. These measures have a computerized format and are nationally standardized. The Gray Oral Reading Test measures reading comprehension. Participants are asked to read a set of passages and recall specific details from the stories. The Woodcock Johnson Understanding Directions measures listening comprehension. Participants listen to a series of complex instructions, then follow the directions by pointing to various objects in a colored picture.
Cognitive exercises using the Lumosity Brain Games program will be used simultaneously with the tDCS intervention. Participants will be asked to engage in training for 20 minutes a day, two days per week over 5 weeks. This program involves cognitive exercises designed to enhance executive function and processing speed.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kevin Krull, PhD
- Organization
- St. Jude Children's Research Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Krull, PhD
St. Jude Children's Research Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2014
First Posted
January 12, 2015
Study Start
January 12, 2015
Primary Completion
July 20, 2017
Study Completion
July 20, 2017
Last Updated
September 18, 2023
Results First Posted
August 24, 2018
Record last verified: 2023-08