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Completed

NCT Number: NCT02336282

Treatment 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

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Key information

Conditions

Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

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.

Other names: tDCS, Transcranial Electrical Stimulation 1x1 Clinical Trials Device, Soterix Transcranial Direct Current Stimulator Clinical Trials, Soterix Medical Device 1x1-CT

SHAM

Device

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.

Other names: placebo

Cognitive Assessment

Other

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.

Other names: NIH Toolbox Cognitive Battery, Gray Oral Reading Test, Woodcock Johnson Understanding Directions

Brain Games Stimulation

Other

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.

Other names: Lumosity Brain Games, www.lumosity.com

Primary outcomes

  1. Feasibility of At Home tDCS Intervention

    Time frame: 5 weeks after participant enrollment

    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.

Secondary outcomes

  1. Digit Span Forward

    Time frame: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.

    Digit Span Forward, Longest Digits Forward: 0-9; higher score indicates more digits recalled. Higher scores are better.

  2. Neurocognitive Questionnaire: CCSS-NCQ

    Time frame: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.

    The CCSS-NCQ is a 25 item self-report questionnaire to assess cognitive function across multiple domains in cancer survivors. Participant responses range from 1-3 for each item with higher score indicating more problems. Domain scores are created by summing the relevant item scores for each domain. Score ranges:

    • NCQ Task Efficiency: 9-27.
    • NCQ Emotional Regulation: 3-9.
    • NCQ Organization: 3-9.
    • NCQ Memory: 4-12.

  3. NIH Toolbox Card Sort Task

    Time frame: After active and sham interventions administered on day one and day two of the trial

    The Card Sort Task measures cognitive flexibility and attention. Pictures are presented varying along two dimensions (e.g., shape and color). Participants must sort the pictures based on a given dimension. Scores range from 0-40 with higher scores indicating better function.

  4. NIH Toolbox Flanker Task

    Time frame: After active and sham interventions administered on day one and day two of the trial

    The Flanker Task measures attention and inhibitory control. Participant focuses on a given stimulus while inhibiting attention to stimuli flanking it. Scores range from 0-40 with higher scores indicating better function.

  5. NIH Toolbox Working Memory Function

    Time frame: After active and sham interventions administered on day one and day two of the trial

    The Working Memory Task measures working memory. Participant recalls and sequences different visually and orally presented stimuli. Scores range from 0-28 with higher scores indicating better working memory.

  6. Digit Span Backward

    Time frame: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.

    Digit Span Backward, Longest Digits Backward: 0-8; higher score indicates more digits recalled. Higher scores are better.

  7. Verbal Fluency

    Time frame: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.

    Verbal Fluency: minimum 0 with no maximum; Count of how many words were generated in 60 seconds per letter with three letters used with no top limit. Higher scores are better.

  8. Oral Trail Making Part A

    Time frame: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.

    Oral Trail Making Part A: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.

  9. Oral Trail Making Part B

    Time frame: Baseline at participant enrollment and 5 week follow-up, results of measurements from both time points were reported in the following table.

    Oral Trail Making Part B: minimum 0 with no maximum amount of time in seconds to say the given letters and numbers. Higher scores are worse.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Official study title

Feasibility and Efficacy of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 12, 2015
Registry last updated
Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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