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Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease
Sponsor: St. Jude Children's Research Hospital
Summary
Participants are being asked to take part in this clinical trial, a type of research study, because investigators want to learn more about oxygen usage in the brain. Patients diagnosed with sickle cell disease are at risk for difficulties with thinking and academic skills. The brain requires a consistent supply of oxygen for normal function, but this supply is reduced among patients with sickle cell disease. The development of new treatments to improve cerebrovascular functioning is needed to limit these difficulties. Transcranial photobiomodulation (i.e., light stimulation to the brain) has the potential to improve cerebrovascular and neurocognitive functioning among patients with sickle cell disease.Participants will be selected randomly (like the flip of a coin) to receive either active light therapy or placebo (no active light treatment). Primary Objectives * Measure the participation rate in a study of transcranial photobiomodulation to improve cognitive functioning in a sample of children with sickle cell disease (ages 8- 17 years). * Assess self- and caregiver-reported ratings of feasibility and acceptability. * Evaluate the frequency and nature of side effects associated with transcranial photobiomodulation. Secondary Objectives * To assess the change in cognitive performance associated with transcranial photobiomodulation compared to a sham control condition. * To measure changes in cerebrovascular oxygenation (oxygenated and deoxygenated hemoglobin) following transcranial photobiomodulation compared to a sham control condition.
Key Details
Gender
All
Age Range
8 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04
Completion Date
2029-12
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Active Transcranial Photobiomodulation (TPBM)
CytonBrite, 1064nm LED
Sham Transcranial photobiomodulation (TPBM)
Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.