Clinical trial NCT04007601: Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
Official title: Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Keywords: Acute Lymphoblastic Leukemia
Neurocognitive impairment
Executive dysfunction
Survivorship
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-05
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Eligible participants will be randomized to receive 1 mA direct current stimulation over the left dorsolateral prefrontal cortex or placebo/sham for 20 minutes. All participants will receive home-based computerized cognitive training. Participants will complete tDCS paired with cognitive training 2 times per week for 6-months.

Eligibility criteria: 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

Primary outcomes:
measure: Direct Testing of Executive Function: Change in Working Memory from baseline to 6 months
timeFrame: Baseline & 6-month follow-up
measure: Direct Testing of Executive Function: Change in Cognitive Flexibility in baseline to 6 months
timeFrame: Baseline & 6-month follow-up
measure: Direct Testing of Executive Function: Change in Verbal Fluency from baseline to 6 months
timeFrame: Baseline & 6-month follow-up
Secondary outcomes:
measure: Change in Patient-Reported Symptoms of Executive Functioning from baseline to 6 months
timeFrame: Baseline and 6-month follow-up
measure: Change in Patient-Reported Symptoms of Executive Functioning from baseline to 6 months
timeFrame: Baseline and 6-month follow-up
measure: Change in Brain Connectivity from baseline to 6 months
timeFrame: Baseline and 6-month follow-up
measure: Change in Regional Brian Activation from baseline to 6 months
timeFrame: Baseline and 6-month follow-up
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Tara Brinkman, PhD
role: PRINCIPAL_INVESTIGATOR
References: