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

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

NCT ID: NCT05550948

Condition: ALL
Hodgkin Lymphoma
Cancer
Survivorship

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Device Feasibility

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Masking description: The proposed study is a double-blind, randomized placebo-controlled pilot study of remotely delivered tPBM paired with cognitive training.

Intervention:

Intervention type: Device
Intervention name: Transcranial photobiomodulation (tPBM) - Mobile System
Description: 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.
Arm group label: alpha tPBM + cognitive training
Arm group label: gamma tPBM + cognitive training
Arm group label: sham tPBM + cognitive training

Other name: Vielight portable tPBM NeURO device.

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.

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: St. Jude Children's Research Hospital

Address:
City: Memphis
Zip: 38105
Country: United States

Status: Recruiting

Contact:
Last name: Nicholas S Phillips, MD, PhD

Contact backup:

Phone: 866-278-5833
Email: referralinfo@stjude.org

Start date: January 5, 2023

Completion date: August 2025

Lead sponsor:
Agency: St. Jude Children's Research Hospital
Agency class: Other

Source: St. Jude Children's Research Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05550948
http://www.stjude.org
http://www.stjude.org/protocols