Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

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Brief Title

Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

Official Title

Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

Brief Summary

      Long-term survivors of ALL are at-risk for neurocognitive impairment, particularly in the
      area of executive functioning. Relatively limited research has focused on interventions for
      improving neurocognitive outcomes in long-term survivors of ALL. A promising technique for
      cognitive enhancement is Transcranial Direct Current Stimulation (tDCS) which differs from
      conventional cognitive remediation approaches in that it directly stimulates specific brain
      regions responsible for cognitive processes and activates functional networks similar to
      those activated during cognitive training.

      Primary Objective

      To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS) paired
      with remote cognitive training on direct testing of executive function in survivors of ALL.

      Secondary Objectives

        -  To evaluate the efficacy of home-based transcranial direct current stimulation (tDCS)
           paired with remote cognitive training on patient-reported symptoms of executive
           dysfunction in survivors of ALL.

        -  To examine the effects of home-based tDCS paired with remote cognitive training on
           patterns of regional brain activation as measured by functional magnetic resonance
           imaging.

        -  To examine the effects of home-based tDCS paired with remote cognitive training on white
           matter integrity and structure as measured by diffusion tensor imaging.
    

Detailed Description

      Eligible participants will be randomized to receive 1 mA direct current stimulation over the
      left dorsolateral prefrontal cortex or placebo/sham for 20 minutes. All participants will
      receive home-based computerized cognitive training. Participants will complete tDCS paired
      with cognitive training 2 times per week for 6-months.
    


Study Type

Interventional


Primary Outcome

Direct Testing of Executive Function: Change in Working Memory from baseline to 6 months

Secondary Outcome

 Change in Patient-Reported Symptoms of Executive Functioning from baseline to 6 months

Condition

Acute Lymphoblastic Leukemia

Intervention

Active tDCS

Study Arms / Comparison Groups

 Active tDCS
Description:  Remotely delivered active tDCS + cognitive training

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

104

Start Date

December 12, 2019

Completion Date

April 1, 2025

Primary Completion Date

April 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Completed treatment for acute lymphoblastic leukemia (ALL) at SJCRH < 21 years at
             diagnosis

          -  Enrolled on St. Jude Lifetime Cohort Study

          -  >5 years post-diagnosis

          -  >2 years post-treatment completion

          -  Currently between 18 and 39 years of age

          -  English language proficiency

          -  Executive dysfunction defined as having an age-adjusted standard score <16th
             percentile on Trail Making Test Part B, Controlled Oral Word association Test, or
             Digit Span Backward

          -  Patient-reported executive dysfunction defined as a standard score >84th percentile on
             the Childhood Cancer Survivor Study Neurocognitive Questionnaire or the Behavior
             Rating Scale of Executive Function

        Exclusion Criteria:

          -  Full scale intelligence score <80

          -  Currently taking medication intended to treat neurocognitive impairment (e.g.
             stimulants)

          -  Participated in a past trial of neurostimulation

          -  Female who is pregnant or breastfeeding

          -  History of seizures within the past year

          -  Implanted medical devices or metal in the head

          -  History of head injury or a neurodevelopmental disorder (i.e. genetic disorder,
             hypoxic-ischemic encephalopathy) associated with neurocognitive impairment and
             unrelated to cancer treatment
      

Gender

All

Ages

18 Years - 39 Years

Accepts Healthy Volunteers

No

Contacts

Tara Brinkman, PhD, 866-278-5833, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04007601

Organization ID

NEUROSTIM

Secondary IDs

R01CA239630

Responsible Party

Sponsor

Study Sponsor

St. Jude Children's Research Hospital

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Tara Brinkman, PhD, Principal Investigator, St. Jude Children's Research Hospital


Verification Date

January 2020