Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/26/2018 |
| Start Date: | January 12, 2015 |
| End Date: | June 9, 2017 |
Feasibility and Efficacy of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
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
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
tDCS is a form of non-invasive brain stimulation and is a potentially useful tool to enhance
cognitive function. This study uses an at-home intervention of tDCS and cognitive training
and examines its potential usefulness at improving executive function in ALL survivors.
Investigators will use tDCS to apply a low electrical current to the participant's scalp in
the area of the brain associated with fluent and flexible thinking. The current may make that
area of the brain work better for a short period of time. During this time, the participant
will play computer games designed to train the brain to work more fluently flexibly.
Researchers at St. Jude Children's Research Hospital want to see if pairing the electrical
stimulation with the brain games at home is a feasible method to improve cognitive abilities
in long-term survivors of childhood ALL.
In the first part of this study, the short-term effect of tDCS intervention will be evaluated
in the clinical setting using a randomized cross-over trial. The survivors will be randomized
to receive either the tDCS intervention or Sham on day 1, with the other treatment given on
day 2. Neurocognitive testing will be conducted within two hours of completing stimulation
each day.
In the second part of this study, the feasibility and potential efficacy of
self-administration of the tDCS intervention paired with cognitive training will be evaluated
over 5 weeks. Research participants will be taught to use the mobile tDCS device and will be
provided one to take home. The device will be programmed by the investigators in advance to
control the intensity and duration of the stimulation. The research participants will use the
device twice per week as directed. Within two hours of completing each tDCS session
participants will complete 20 minutes of cognitive training using a mobile app installed on
an iPad. Neurocognitive testing will be conducted pre- and post- intervention.
cognitive function. This study uses an at-home intervention of tDCS and cognitive training
and examines its potential usefulness at improving executive function in ALL survivors.
Investigators will use tDCS to apply a low electrical current to the participant's scalp in
the area of the brain associated with fluent and flexible thinking. The current may make that
area of the brain work better for a short period of time. During this time, the participant
will play computer games designed to train the brain to work more fluently flexibly.
Researchers at St. Jude Children's Research Hospital want to see if pairing the electrical
stimulation with the brain games at home is a feasible method to improve cognitive abilities
in long-term survivors of childhood ALL.
In the first part of this study, the short-term effect of tDCS intervention will be evaluated
in the clinical setting using a randomized cross-over trial. The survivors will be randomized
to receive either the tDCS intervention or Sham on day 1, with the other treatment given on
day 2. Neurocognitive testing will be conducted within two hours of completing stimulation
each day.
In the second part of this study, the feasibility and potential efficacy of
self-administration of the tDCS intervention paired with cognitive training will be evaluated
over 5 weeks. Research participants will be taught to use the mobile tDCS device and will be
provided one to take home. The device will be programmed by the investigators in advance to
control the intensity and duration of the stimulation. The research participants will use the
device twice per week as directed. Within two hours of completing each tDCS session
participants will complete 20 minutes of cognitive training using a mobile app installed on
an iPad. Neurocognitive testing will be conducted pre- and post- intervention.
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.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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