Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivo… (NCT05550948) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer
United States44 participantsStarted 2023-01-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ind…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants who completed a two-month trial of paired photobiomodulation (PBM) therapy and cognitive training