NCT04007601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

December 12, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3.5 years

First QC Date

June 18, 2019

Last Update Submit

July 24, 2023

Conditions

Acute Lymphoblastic Leukemia

Keywords

Acute Lymphoblastic LeukemiaNeurocognitive impairmentExecutive dysfunctionSurvivorship

Outcome Measures

Primary Outcomes (3)

  • Direct Testing of Executive Function: Change in Working Memory from baseline to 6 months

    Digit Span Backward: Digit Span Backward (DSB), from the Digit Span subtest on the WAIS-IV, is a measure of working memory. The number of digits recalled in the longest span is converted to a standard z-score using age-based norms (Mean=0, SD=1).

    Baseline & 6-month follow-up

  • Direct Testing of Executive Function: Change in Cognitive Flexibility in baseline to 6 months

    Trail Making Test Part B (Trails B): This is a timed task that requires a participant to shift his/her attention adaptively and flexibly. Age-based standardized z-scores are calculated (Mean=0, SD=1).

    Baseline & 6-month follow-up

  • Direct Testing of Executive Function: Change in Verbal Fluency from baseline to 6 months

    Controlled Oral Word Association (COWA): This is a task of cognitive/verbal fluency that measures spontaneous production of words beginning with a designated letter or category. Age-based standardized z-scores are calculated (Mean=0, SD=1).

    Baseline & 6-month follow-up

Secondary Outcomes (4)

  • Change in Patient-Reported Symptoms of Executive Functioning from baseline to 6 months

    Baseline and 6-month follow-up

  • Change in Patient-Reported Symptoms of Executive Functioning from baseline to 6 months

    Baseline and 6-month follow-up

  • Change in Brain Connectivity from baseline to 6 months

    Baseline and 6-month follow-up

  • Change in Regional Brian Activation from baseline to 6 months

    Baseline and 6-month follow-up

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Remotely delivered active tDCS + cognitive training

Device: Active tDCS

Sham tDCS

PLACEBO COMPARATOR

Remotely delivered sham tDCS + cognitive training

Device: Sham tDCS

Interventions

Active tDCSDEVICE

Participants will receive active 1mA direct current stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.

Active tDCS
Sham tDCSDEVICE

Participants will receive sham (no direct current) stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.

Sham tDCS

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Tara Brinkman, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

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
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

July 5, 2019

Study Start

December 12, 2019

Primary Completion

June 21, 2023

Study Completion

June 21, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

US(1)