Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia

Summary

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

Conditions

• Acute Lymphoblastic Leukemia

Interventions

DEVICE

transcranial Direct Current Stimulation (tDCS)

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.

DEVICE

Sham

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

Cognitive Assessment

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

Brain Games Stimulation

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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital

  lead OTHER

Principal Investigators

• Kevin Krull, PhD · St. Jude Children's Research Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-12

Primary Completion

2017-07-20

Completion

2017-07-20

FDA Device

Yes

Countries

• United States

Study Locations