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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-05

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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ALL Hodgkin Lymphoma Cancer Survivorship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The proposed study is a double-blind, randomized placebo-controlled pilot study of remotely delivered tPBM paired with cognitive training.

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)

Group Type EXPERIMENTAL

Transcranial photobiomodulation (tPBM) - Mobile System

Intervention Type 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.

gamma tPBM + cognitive training

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

Group Type EXPERIMENTAL

Transcranial photobiomodulation (tPBM) - Mobile System

Intervention Type 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.

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)

Group Type EXPERIMENTAL

Transcranial photobiomodulation (tPBM) - Mobile System

Intervention Type 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.

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.

Intervention Type DEVICE

Other Intervention Names

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Vielight portable tPBM NeURO device.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

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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