Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease

Starting soon · Not applicable · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

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 facts

Study ID

NCT06797583

Run by

St. Jude Children's Research Hospital

People needed

60

Starts

2026-08-01

Expected to finish

2029-12-01

Last updated by the study team

2026-06-17

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient diagnosed with sickle cell disease of any genotype
• Enrolled in the Sickle Cell Clinical Research and Intervention Program (SCCRIP)
• Between the ages of 8 to 17 years
• Primary language is English
• Participant and Parent/Legal Guardian is willing to participate and provide consent/assent according to institutional guidelines

You may not qualify if…

• History of an abnormal transcranial doppler screening
• History of a documented silent cerebral infarct
• History of documented central nervous system injury, including a traumatic brain injury, Moya Moya disease, or overt stroke
• Participant received transfusion treatment within the past three months.

Full record on ClinicalTrials.gov

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