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NCT06797583Not yet recruiting

Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
12 Dec 2024
Start date
Nov 2026
Primary completion date
Dec 2027
Lead sponsor
St. Jude Children's Research Hospital
NCT number
NCT06797583

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From Nov 2026 to the primary completion date, Dec 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant received transfusion treatment within the past three months.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 8 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.