This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT02336282
First received: December 18, 2014
Last updated: June 21, 2017
Last verified: January 2017
  Purpose

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

Condition Intervention
Acute Lymphoblastic Leukemia Device: transcranial Direct Current Stimulation (tDCS) Device: Sham Other: Cognitive Assessment Other: Brain Games Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Supportive Care
Official Title: Feasibility and Efficacy of Transcranial Direct Current Stimulation (tDCS) and Cognitive Training for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Number of participants who successfully complete 5 sessions out of 10 [ Time Frame: 5 weeks after participant enrollment ]
    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 Outcome Measures:
  • Change in cognitive testing scores [ Time Frame: Baseline at participant enrollment and 5 weeks after baseline ]
    The improvement in cognitive testing scores from baseline to 5-week follow up will be done using matched pair one sample t-tests.

  • Change in scores on the NIH Toolbox Card Sort task [ Time Frame: After active and sham interventions administered on day one and day two of the trial ]
    The improvement in the scores on the NIH Toolbox Card Sort task between tDCS and sham, will be done using matched pair one sample t-test.

  • Change in scores on the NIH Toolbox Flanker task [ Time Frame: After active and sham interventions administered on day one and day two of the trial ]
    The improvement in the scores on the NIH Toolbox Flanker task between tDCS and sham, will be done using matched pair one sample t-test.

  • Change in scores on the NIH Toolbox Working Memory task [ Time Frame: After active and sham interventions administered on day one and day two of the trial ]
    The improvement in the scores on the NIH Toolbox Working Memory task between tDCS and sham, will be done using matched pair one sample t-test.


Enrollment: 53
Actual Study Start Date: January 12, 2015
Study Completion Date: June 9, 2017
Primary Completion Date: June 9, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tDCS on Day 1

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.

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.
Other Names:
  • tDCS
  • Transcranial Electrical Stimulation 1x1 Clinical Trials Device
  • Soterix Transcranial Direct Current Stimulator Clinical Trials
  • Soterix Medical Device 1x1-CT
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 Name: placebo
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 Names:
  • NIH Toolbox Cognitive Battery
  • Gray Oral Reading Test
  • Woodcock Johnson Understanding Directions
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.
Other Names:
  • Lumosity Brain Games
  • www.lumosity.com
Active Comparator: tDCS on Day 2

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.

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.
Other Names:
  • tDCS
  • Transcranial Electrical Stimulation 1x1 Clinical Trials Device
  • Soterix Transcranial Direct Current Stimulator Clinical Trials
  • Soterix Medical Device 1x1-CT
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 Name: placebo
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 Names:
  • NIH Toolbox Cognitive Battery
  • Gray Oral Reading Test
  • Woodcock Johnson Understanding Directions
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.
Other Names:
  • Lumosity Brain Games
  • www.lumosity.com

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 of 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02336282

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Kevin Krull, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02336282     History of Changes
Other Study ID Numbers: ALLSTIM
NCI-2015-00050 ( Registry Identifier: NCI Clinical Trial Registration Program )
Study First Received: December 18, 2014
Last Updated: June 21, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by St. Jude Children's Research Hospital:
Adult survivor of acute lymphoblastic leukemia
Executive dysfunction
Transcranial direct current stimulation
Cancer prevention and control

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on June 23, 2017