Neurostimulation In Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)
NCT ID: NCT04007601
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
127 participants
INTERVENTIONAL
2019-12-12
2023-06-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment for Executive Dysfunction in Adult Survivors of Childhood Acute Lymphoblastic Leukemia
NCT02336282
Cognitive Intervention at the End of Therapy for Survivors of Childhood ALL Treated on TOTXVI
NCT03187977
Feasibility and Tolerability of Transcranial Direct Current Stimulation With Concurrent Cognitive Training
NCT02726763
Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome
NCT02859389
Inattention in Childhood Cancer Survivors
NCT00636337
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active tDCS
Remotely delivered active tDCS + cognitive training
Active tDCS
Participants will receive active 1mA direct current stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.
Sham tDCS
Remotely delivered sham tDCS + cognitive training
Sham tDCS
Participants will receive sham (no direct current) stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Active tDCS
Participants will receive active 1mA direct current stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.
Sham tDCS
Participants will receive sham (no direct current) stimulation over the left dorsolateral prefrontal cortex for 20 minutes. Cognitive training: Participants will complete 20 minutes of online cognitive training via Lumosity two days per week for a 6-month intervention period.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Enrolled on St. Jude Lifetime Cohort Study
* ≥ 5 years post-diagnosis of ALL
* ≥ 2 years post-treatment completion deemed to impact the central nervous system.
* 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
* 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
* Currently receiving cancer directed therapy
18 Years
39 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
St. Jude Children's Research Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tara Brinkman, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEUROSTIM
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.