Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorSt. Jude Children's Research Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Active Transcranial Photobiomodulation (TPBM)
  • Sham Transcranial photobiomodulation (TPBM)

Treatment groups

60 Participants
are divided into 4 treatment groups

Locations

This trial has no locations