CClinicalTrials.gg
CompletedNCT05550948Updated Oct 2, 2026

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

An interventional study of Transcranial photobiomodulation (tPBM) - Mobile System in ALL, Hodgkin Lymphoma and Cancer, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by St. Jude Children's Research Hospital · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was Jun 2025, 1 year 4 months ago, and no results have been posted to the registry.
Updated Oct 2, 2026Now CompletedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • ALL
  • Hodgkin Lymphoma
  • Cancer
  • Survivorship
03

In context

Hodgkin Disease

885 studies on the registry are indexed under Hodgkin Disease; 132 are open to participants now.

This study's enrollment of 44 is close to the median of 44 across 726 interventional studies indexed under Hodgkin Disease.

Browse Hodgkin Disease studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • 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

Interventions

  • DeviceTranscranial photobiomodulation (tPBM) - Mobile System

    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.

    Also known as: Vielight portable tPBM NeURO device.

06

What researchers measure

Primary outcomes

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

    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).

    Time frame: 4 months after participant enrollment

Secondary outcomes

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

    RVLT is a test that evaluate working memory.

    Time frame: 2 month and 4 months after enrollment

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

    RVDL is a test that evaluate working memory.

    Time frame: 2 month and 4 months after enrollment

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

    The Stroop test is a test that evaluates Inhibitory control.

    Time frame: 2 month and 4 months after enrollment

  4. CNS Vital Signs implemented Shifting Attention Test.

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

    Time frame: 2 month and 4 months after enrollment

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

    The CPT test is a test that evaluates attention.

    Time frame: 2 month and 4 months after enrollment

07

Study locations

1 site
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Status
Active, not recruiting→Completed
changed Oct 2, 2026
Study completion
Aug 2026→Jul 9, 2026 (actual)
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Active, not recruiting→Completed
    Study completion Aug 2026→Jul 9, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05550948
Lead sponsor
St. Jude Children's Research Hospital
Responsible party
Sponsor
First posted
Sep 22, 2022
Start date
Jan 5, 2023
Primary completion
Jun 6, 2025
Completion
Jul 9, 2026
Last update
Oct 2, 2026

Study contacts

Nicholas Phillips, MD,PhD
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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