Improving cognition in childhood cancer survivors using light therapy
Use of Transcranial Photobiomodulation to Improve Cognition and Self-Reported Outcomes in Survivors of Childhood Cancer
This study is testing whether a new light therapy combined with brain training can help childhood cancer survivors improve their thinking skills and feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT05550948 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility of using home-based transcranial photobiomodulation (tPBM) combined with remote cognitive training to enhance cognitive performance in survivors of acute lymphoblastic leukemia (ALL) and Hodgkin's lymphoma (HL). Participants will be randomized to receive either active tPBM at alpha or gamma frequencies, or a sham treatment, three times a week for two months. The study aims to assess improvements in cognitive functions such as attention and memory, as well as self-reported symptoms related to executive dysfunction, sleep, and mood. The intervention targets specific brain networks associated with cognitive processing.
Who should consider this trial
Good fit: Ideal candidates are survivors of ALL or HL who are at least 18 years old, have completed treatment for at least two years, and exhibit signs of executive dysfunction.
Not a fit: Patients with major psychiatric conditions or those currently taking medications for neurocognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive function and quality of life for childhood cancer survivors.
How similar studies have performed: While the use of tPBM is a novel approach in this context, similar studies have shown promise in improving cognitive function in other populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Nicholas Phillips, MD,PhD — St. Jude Children's Research Hospital
- Study coordinator: Nicholas Phillips, MD,PhD
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.