Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- 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).
研究概览
简要总结
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.
详细描述
Patients diagnosed with sickle cell disease (SCD) of any genotype, between the ages of 8-17 years will be recruited through the Sickle Cell Clinical Research and Intervention Program (SCCRIP). Recruited participants will be selected randomly to receive TPBM (CytonBrite, 1064nm LED) or a sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization. The groups will be divided by genotype (SS/SB0 and SC/SB+) and age (8-12 and 13-17) such that there will be four subgroups that are randomly assigned.
Participants will be asked to complete a baseline side effects questionnaire (modified Patient Report of Incidence of Side Effects and Visual Analog Pain Scale) and caregivers will complete a medical/demographics questionnaire.
After completing the baseline questionnaires, a functional near infrared spectroscopy (fNIRS) headband (NIRSport2) will be fitted for the participant based on the circumference of their head. The cap is then fitted with emitters and detectors to capture changes in cerebral hemodynamics in the frontal cortex.
Prior to wearing the headband, participants will complete an assessment to estimate overall intellectual abilities based on their vocabulary skills (NIH Picture Vocabulary Test). Then the participants will complete four cognitive measures associated with frontal functioning while wearing the fNIRS headband. These tasks measure processing speed and working memory and take approximately 5-6 minutes each to complete.
Photobiomodulation using the CytonBrite PBM device will be performed immediately following the initial fNIRS exam. The CytonBrite headpiece will be placed on the head. The six LED probes will be positioned over the forehead, and the probes will be adjusted per device specifications to maximize light penetration to the prefrontal cortex. The patient will receive 10 minutes of continuous wave light or sham.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Research participants will be told of their assigned group (sham control or intervention) after all study procedures are completed.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
SCD Genotype - SS/SB0; Age 13-17 Years
Transcranial photobiomodulation (TPBM), a light-based treatment using a fNIRS headset to capture changes in cerebral hemodynamics in the prefrontal cortex associated with (TPBM).
干预措施: Active Transcranial Photobiomodulation (TPBM) (Device)
SCD Genotype SS/SB0; Age 8-12 Years
Transcranial photobiomodulation (TPBM), a light-based treatment using a fNIRS headset to capture changes in cerebral hemodynamics in the prefrontal cortex associated with (TPBM).
干预措施: Active Transcranial Photobiomodulation (TPBM) (Device)
SCD Genotype - SC/SB+; Age 8-12 Years
Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.
干预措施: Sham Transcranial photobiomodulation (TPBM) (Device)
SCD Genotype - SC/SB+; Age 13-17 Years
Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.
干预措施: Sham Transcranial photobiomodulation (TPBM) (Device)
结局指标
主要结局
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).
时间窗: Through study completion of all enrolled participants, estimated to be 3 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.
时间窗: Immediately post intervention period
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.
时间窗: Immediately post intervention period
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.
时间窗: Immediately post intervention period
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.
Assess caregiver-reported ratings of acceptability.
时间窗: Immediately post intervention period
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.
Evaluate the frequency and nature of side effects associated with transcranial photobiomodulation.
时间窗: Immediately before intervention, immediately after intervention and one week post intervention period
Descriptive statistics of self-report ratings on the Visual Analog Pain Scale will be reported.
Evaluate the frequency and nature of side effects associated with transcranial photobiomodulation.
时间窗: Immediately before intervention, immediately after intervention and one week post intervention period.
The frequency and percentage of each type of side effect will be calculated along with summary statistics for the nature and frequency of side effects.
次要结局
- To assess the change in cognitive performance associated with transcranial photobiomodulation(Assessed immediately before and immediately after intervention.)
- To assess the change in cognitive performance associated with transcranial photobiomodulation.(Assessed immediately before and immediately after intervention)
- To assess the change in cognitive performance associated with a sham control condition.(Assessed immediately before and immediately after intervention)
- To measure changes in cerebrovascular oxygenation (oxygenated and deoxygenated hemoglobin) following transcranial photobiomodulation.(Assessed immediately before and immediately after intervention.)
- To measure changes in cerebrovascular oxygenation (oxygenated and deoxygenated hemoglobin) following a sham control condition.(Assessed immediately before and immediately after intervention.)
- To assess the change in cognitive performance associated with a sham control condition.(Assessed immediately before and immediately after intervention.)