Clinical trial NCT05550948: Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer
Official title: Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ALL
Hodgkin Lymphoma
Cancer
Survivorship
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

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.

Primary outcomes:
measure: Number of participants who completed a two-month trial of paired photobiomodulation (PBM) therapy and cognitive training
timeFrame: 4 months after participant enrollment
Secondary outcomes:
measure: CNS Vital Signs adaptions of the Rey auditory verbal learning test (RVLT).
timeFrame: 2 month and 4 months after enrollment
measure: CNS Vital Signs adaptions of the Rey visual design learning (RVDL) test.
timeFrame: 2 month and 4 months after enrollment
measure: CNS Vital Signs implemented Stroop color and word test.
timeFrame: 2 month and 4 months after enrollment
measure: CNS Vital Signs implemented Shifting Attention Test.
timeFrame: 2 month and 4 months after enrollment
measure: CNS Vital Signs implementation of the Continuous Performance Test (CPT).
timeFrame: 2 month and 4 months after enrollment
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Nicholas Phillips, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: