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

April 22, 2026 updated by: St. Jude Children's Research Hospital

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.

Study Overview

Status

Active, not recruiting

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

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: alpha tPBM + cognitive training
three days per week for a 2-month intervention period (5 ALL and 5 HL)
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.
Experimental: gamma tPBM + cognitive training
three days per week for a 2-month intervention period (5 ALL and 5 HL)
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.
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 months after participant enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 month and 4 months after enrollment
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.
2 month and 4 months after enrollment
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.
2 month and 4 months after enrollment
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.
2 month and 4 months after enrollment
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.
2 month and 4 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nicholas Phillips, MD,PhD, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2023

Primary Completion (Actual)

June 6, 2025

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PBMP
  • NCI-2022-09116 (Other Identifier: NCI Clinical Trial Registration Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer

Clinical Trials on Transcranial photobiomodulation (tPBM) - Mobile System

Subscribe