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NCT05550948 | Recruiting | ALL

Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer
Sponsor:

St. Jude Children's Research Hospital

Brief Summary:

Survivors of childhood cancer are at greater risk for long-term cognitive impairments that include attention, executive function, intelligence, memory, and processing speed. The participants are a survivor of acute lymphoblastic leukemia (ALL) or Hodgkin's lymphoma (HL). Because of your treatment the participant may have developed trouble with thinking and learning. Primary Objective To evaluate the feasibility of using home-based tPBM paired with remote cognitive training to improve cognitive performance in survivors of ALL and HL. Secondary Objectives To estimate the potential efficacy of alpha and gamma frequency tPBM on cognitive performance in survivors of ALL and HL. Exploratory Objectives To estimate the effects of home-based tPBM paired with remote cognitive training on patient reported symptoms of executive dysfunction, sleep, depression, anxiety, fatigue, and pain in survivors of ALL and HL.

Condition or disease

ALL

Hodgkin Lymphoma

Cancer

Survivorship

Intervention/treatment

Transcranial photobiomodulation (tPBM) - Mobile System

Phase

Not Applicable

Detailed Description:

Survivors with ALL and HL with identified executive function impairment will be randomized to receive stimulation with alpha tPBM + cognitive training, gamma tPBM + cognitive training or sham tPBM + cognitive training three days per week for a 2-month intervention period The tPBM will be applied to nodes in the default mode network.}}

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking : Triple
Masking Description : The proposed study is a double-blind, randomized placebo-controlled pilot study of remotely delivered tPBM paired with cognitive training.
Primary Purpose : Device Feasibility
Official Title : Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer
Actual Study Start Date : January 5, 2023
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : February 2025
Arm Intervention/treatment

Experimental: alpha tPBM + cognitive training

three days per week for a 2-month intervention period (5 ALL and 5 HL)

Device: Transcranial photobiomodulation (tPBM) - Mobile System

Experimental: gamma tPBM + cognitive training

three days per week for a 2-month intervention period (5 ALL and 5 HL)

Device: Transcranial photobiomodulation (tPBM) - Mobile System

Experimental: sham tPBM + cognitive training

Sham stimulations will act as the control for this study three days per week for a 2-month intervention period (5 ALL and 5 HL)

Device: Transcranial photobiomodulation (tPBM) - Mobile System
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Completed treatment for acute lymphoblastic leukemia (ALL) or Hodgkin's Lymphoma (HL) at SJCRH.
  • Enrolled in SJLIFE, and less than 21 years of age at diagnosis.
  • 18 years of age or older at time of enrollment.
  • 2 years or greater post-treatment completion of cancer directed therapy and not currently receiving any cancer directed therapy.
  • English language proficiency.
  • Access to WiFi.
  • Executive dysfunction defined as having an age-adjusted standard score less than 16th percentile on objectively assessed cognitive test or patient-reported executive dysfunction defined as having a standard score greater than 84th percentile within 3 years of time of enrollment.
Exclusion Criteria
  • Estimated intelligence score less than 80.
  • Currently taking medication intended to treat neurocognitive impairment (i.e., stimulants).
  • Major psychiatric condition.
  • Alcohol abuse in the past year (AUDIT) [greater than or equal to 13 for women and greater than or equal to 15 for men]. The Alcohol Use Disorders Identification Test (AUDIT) will be used to screen for individuals who have active alcohol-use disorders.
  • Drug abuse in the past year (DAST-10) [ greater than or equal to 3 for women or men] The Drug Abuse Screen Test (DAST-10) will be used to screen for individuals with active drug abuse.
  • History of neurologic condition or genetic disorder associated with neurocognitive impairment unrelated to cancer diagnosis or treatment.
  • Enrolled on another independent cognitive intervention protocol within the last year.
  • Female participants who are pregnant or lactating (determined by participant self-report due to the remote nature of this study)
  • Tattoo or artificial marking in the area where the device will be positioned.
Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer

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Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer

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Locations

Recruiting

United States, Tennessee

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105