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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05550948
• Other study ID #: PBMP
• Secondary ID: NCI-2022-09116
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: February 2025

Study information

• Verified date: September 2023
• Source: St. Jude Children's Research Hospital
• Contact: Nicholas Phillips, MD,PhD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ALL
• Cancer
• Hodgkin Lymphoma
• Survivorship

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CNS Vital Signs adaptions of the Rey auditory verbal learning test (RVLT).	RVLT is a test that evaluate working memory.	2 month and 4 months after enrollment
Secondary	CNS Vital Signs adaptions of the Rey visual design learning (RVDL) test.	RVDL is a test that evaluate working memory.	2 month and 4 months after enrollment
Secondary	CNS Vital Signs implemented Stroop color and word test.	The Stroop test is a test that evaluates Inhibitory control.	2 month and 4 months after enrollment
Secondary	CNS Vital Signs implemented Shifting Attention Test.	The Shifting attention test and Stroop test are tests that are used to measure cognitive flexibility.	2 month and 4 months after enrollment
Secondary	CNS Vital Signs implementation of the Continuous Performance Test (CPT).	The CPT test is a test that evaluates attention.	2 month and 4 months after enrollment

External Links

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