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

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Brief Title

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

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

Brief 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
    

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.
    


Study Type

Interventional


Primary Outcome

Feasibility of At Home tDCS Intervention

Secondary Outcome

 Digit Span Forward

Condition

Acute Lymphoblastic Leukemia

Intervention

transcranial Direct Current Stimulation (tDCS)

Study Arms / Comparison Groups

 tDCS on Day 1
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

53

Start Date

January 12, 2015

Completion Date

June 9, 2017

Primary Completion Date

June 9, 2017

Eligibility 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 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kevin Krull, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02336282

Organization ID

ALLSTIM

Secondary IDs

NCI-2015-00050

Responsible Party

Sponsor

Study Sponsor

St. Jude Children's Research Hospital


Study Sponsor

Kevin Krull, PhD, Principal Investigator, St. Jude Children's Research Hospital


Verification Date

January 2017