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.
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
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.
Parallel
Active Transcranial Photobiomodulation (TPBM)
DeviceCytonBrite, 1064nm LED
Sham Transcranial photobiomodulation (TPBM)
DeviceSham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.
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).
A binary variable indicating whether a participant engaged in the study (1 = participated, 0 = did not participate). Overall participation rate will be calculated as the proportion of participants who engaged in this study.
Assess self-reported ratings of feasibility.
Subgroup analysis and logistic regression analysis will be used to describe factors of interest which may impact participation rates.
Assess self-reported ratings of acceptability.
Subgroup analysis and logistic regression analysis will be used to describe factors of interest which may impact participation rates.
Assess caregiver-reported ratings of feasibility.
Subgroup analysis and logistic regression analysis will be used to describe factors of interest which may impact participation rates. Qualitative metrics will also be used to analyze semi-structured interviews.
To assess the change in cognitive performance associated with transcranial photobiomodulation
For each subject's cognitive performance in both sessions of the psychomotor vigilance task (PVT) and delayed match to sample (DMS) task, an overall cognitive score will be calculated, incorporating both speed (reaction time) and accuracy (number of correct responses), using the rate correct score. This overall cognitive score is equal to the number of correct responses divided by the sum of all reaction times. The behavioral results for all 4 cognitive measures will be analyzed with an independent two-sample t-test comparing performance on these tasks before and after stimulation for two groups with a one-tailed level of significance with p ≤ 0.10.
To assess the change in cognitive performance associated with transcranial photobiomodulation.
Age-standardized scores for the NIH Toolbox List Sorting and NIH Toolbox Pattern Comparison test will be calculated. The behavioral results for all 4 cognitive measures will be analyzed with an independent two-sample t-test comparing performance on these tasks before and after stimulation for two groups with a one-tailed level of significance with p ≤ 0.10.
To assess the change in cognitive performance associated with a sham control condition.
For each subject's cognitive performance in both sessions of the psychomotor vigilance task (PVT) and delayed match to sample (DMS) task, an overall cognitive score will be calculated, incorporating both speed (reaction time) and accuracy (number of correct responses), using the rate correct score. This overall cognitive score is equal to the number of correct responses divided by the sum of all reaction times. The behavioral results for all 4 cognitive measures will be analyzed with an independent two-sample t-test comparing performance on these tasks before and after stimulation for two groups with a one-tailed level of significance with p ≤ 0.10.
To assess the change in cognitive performance associated with a sham control condition.
Age-standardized scores for the NIH Toolbox List Sorting and NIH Toolbox Pattern Comparison test will be calculated. The behavioral results for all 4 cognitive measures will be analyzed with an independent two-sample t-test comparing performance on these tasks before and after stimulation for two groups with a one-tailed level of significance with p ≤ 0.10.
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