Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer
NCT ID: NCT05550948
Last Updated: 2025-07-28
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
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ACTIVE_NOT_RECRUITING
NA
44 participants
INTERVENTIONAL
2023-01-05
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DEVICE_FEASIBILITY
TRIPLE
Study Groups
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alpha tPBM + cognitive training
three days per week for a 2-month intervention period (5 ALL and 5 HL)
Transcranial 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.
gamma tPBM + cognitive training
three days per week for a 2-month intervention period (5 ALL and 5 HL)
Transcranial 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.
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)
Transcranial 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.
Interventions
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Transcranial 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Nicholas Phillips, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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NCI-2022-09116
Identifier Type: OTHER
Identifier Source: secondary_id
PBMP
Identifier Type: -
Identifier Source: org_study_id
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