Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Lymphosarcoma

On 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.

On 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.

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.

transcranial Direct Current Stimulation (tDCS)

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.

Sham

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 Assessment

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.

Brain Games Stimulation

Kevin Krull, PhD

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

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.

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

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.

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

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.

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.

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.

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.

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

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.

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.

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.

St. Jude Children's Research Hospital

PRISE assesses presence of side effects for several biological systems. For each organ/function system, the participant indicates the presence of a side effect, and if present, the tolerability of the side effect (tolerable or distressing). FISER and GRSEB assess side effect impact: frequency, intensity, and burden. Each domain is rated on a 7- point Likert scale.

On Campus Sham tDCS

On Campus tDCS

Participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device 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.

At Home tDCS

During campus visit, following randomized design each participant completed tDCS set to sham, tDCS equipment set to active condition, during two consecutive days. Participants who completed the campus visit session and evaluation then were to complete a single arm treatment of 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad.

Overall Study

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Thirty one participants completed both the tDCS equipment set to sham condition and the tDCS equipment set to active condition. Two of the 33 participants who began the overall study did not complete the second day of the campus visit. Of the 31 who completed both days of the campus visit, 28 completed the at home portion.

All participants completed 10 stimulation sessions over 5 weeks using a mobile tDCS device 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.

At Home Feasibility of tDCS Intervention

Participant enrollment for At Home Feasibility of tDCS intervention n=28 Participants Analyzed (Week 5 reported n=25)

Feasibility of At Home tDCS Intervention

At Home tDCS - Baseline

At Home tDCS - Follow-Up

Digit Span Forward

Task Efficiency

Memory

Organization

Emotional Regulation

Participants completed NCQ questionnaire examiner read

Neurocognitive Questionnaire: CCSS-NCQ

NIH Toolbox Card Sort Task

NIH Toolbox Flanker Task

NIH Toolbox Working Memory Function

Digit Span Backward

Verbal Fluency

Oral Trail Making Part A

Oral Trail Making Part B

Participants completed tDCS set to sham, tDCS equipment set to active condition, then were to complete 10 stimulation sessions over 5 weeks using a mobile tDCS device twice per week. Within two hours of completing each tDCS session, participants were to complete 20 minutes of cognitive training using a mobile application installed on an iPad.

Spots Global Cancer Trial Database for adult survivor of acute lymphoblastic leukemia