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

NCT05550948 | Active Not Recruiting FDA Device

• 2 other identifiers: PBMPNCI-2022-09116
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ALL; Hodgkin Lymphoma; Cancer; Survivorship

Outcome Measures

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).

  4 months after participant enrollment

Secondary Outcomes (5)

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

  2 month and 4 months after enrollment

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

  2 month and 4 months after enrollment

• CNS Vital Signs implemented Stroop color and word test.

  2 month and 4 months after enrollment

• CNS Vital Signs implemented Shifting Attention Test.

  2 month and 4 months after enrollment

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

  2 month and 4 months after enrollment

Study Arms (3)

alpha tPBM + cognitive training

EXPERIMENTAL

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

Device: Transcranial photobiomodulation (tPBM) - Mobile System

gamma tPBM + cognitive training

EXPERIMENTAL

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

Device: Transcranial photobiomodulation (tPBM) - Mobile System

sham tPBM + cognitive training

EXPERIMENTAL

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

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.

Also known as: Vielight portable tPBM NeURO device.

alpha tPBM + cognitive training; gamma tPBM + cognitive training; sham tPBM + cognitive training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older at time of enrollment.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Hodgkin Disease; Neoplasms

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nicholas Phillips, MD,PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The proposed study is a double-blind, randomized placebo-controlled pilot study of remotely delivered tPBM paired with cognitive training.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 22, 2022
• Study Start: January 5, 2023
• Primary Completion: June 6, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)