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NCT Number: NCT05550948

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

ALL Cancer Hemic and Lymphatic Diseases Hodgkin Disease Hodgkin Lymphoma Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Survivorship

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial photobiomodulation (tPBM) - Mobile System

Device

The Vielight NeURO device delivers 810 nm near infrared light via four (4) transcranial LED modules. The LED modules target brain regions associated with a variety of cognitive functions. It can deliver light at two frequencies: Alpha (10 Hz) and Gamma (40 Hz). Alpha oscillations are prominent in healthy brains during wakeful resting and gamma oscillations are associated with activities associated with focus, memory, and cognition.

Other names: Vielight portable tPBM NeURO device.

Primary outcomes

  1. Number of participants who completed a two-month trial of paired photobiomodulation (PBM) therapy and cognitive training

    Time frame: 4 months after participant enrollment

    The trial will be considered feasible if at least 15 of 30 survivors are able to complete 18 of 24 sessions (PBM along with cognitive training).

Secondary outcomes

  1. CNS Vital Signs adaptions of the Rey auditory verbal learning test (RVLT).

    Time frame: 2 month and 4 months after enrollment

    RVLT is a test that evaluate working memory.

  2. CNS Vital Signs adaptions of the Rey visual design learning (RVDL) test.

    Time frame: 2 month and 4 months after enrollment

    RVDL is a test that evaluate working memory.

  3. CNS Vital Signs implemented Stroop color and word test.

    Time frame: 2 month and 4 months after enrollment

    The Stroop test is a test that evaluates Inhibitory control.

  4. CNS Vital Signs implemented Shifting Attention Test.

    Time frame: 2 month and 4 months after enrollment

    The Shifting attention test and Stroop test are tests that are used to measure cognitive flexibility.

  5. CNS Vital Signs implementation of the Continuous Performance Test (CPT).

    Time frame: 2 month and 4 months after enrollment

    The CPT test is a test that evaluates attention.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 22, 2022
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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