Clinical trial NCT06797583: Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease
Official title: Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The fNIRS device uses light to measure blood flow and oxygen levels in the brain. Participants will be assigned to receive transcranial photobiomodulation or a sham condition using a randomized block design. Randomized block design involving 2 (TPBM): 1(sham) randomization. One group will wear fNIRS headset which will deliver light therapy; or a headset with placebo (no light therapy) and complete a series of computer tests while wearing the headset for 10 minutes. 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Following stimulation or sham, the fNIRS cap will be placed in the same location and the same cognitive measures will be completed (4 measures of frontal functioning). Changes in cerebral hemodynamics and cognitive performance on four measures (2 working memory and 2 processing speed tasks) from pre- to post-stimulation will be compared between the two groups. This will take about 30 minutes.

The cap will be removed, and the caregiver and the participant will complete brief rating forms assessing perceived feasibility and acceptability of the intervention (FIM and AIM). Additionally, participants will be asked to report any side effects they experienced immediately following the intervention.

Among the participants that were randomized to TPBM, the sample (both caregiver and participant) will be further randomized to complete a brief (\~10-15 minutes) interview assessing the perceived feasibility and acceptability of the TPBM intervention.

Approximately one-week post-intervention, participants will complete the side effects questionnaires virtually.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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).
timeFrame: Through study completion of all enrolled participants, estimated to be 3 years
measure: Assess self-reported ratings of feasibility.
timeFrame: Immediately post intervention period
measure: Assess self-reported ratings of acceptability.
timeFrame: Immediately post intervention period
measure: Assess caregiver-reported ratings of feasibility.
timeFrame: Immediately post intervention period
measure: Assess caregiver-reported ratings of acceptability.
timeFrame: Immediately post intervention period
measure: Evaluate the frequency and nature of side effects associated with transcranial photobiomodulation.
timeFrame: Immediately before intervention, immediately after intervention and one week post intervention period.
measure: Evaluate the frequency and nature of side effects associated with transcranial photobiomodulation.
timeFrame: Immediately before intervention, immediately after intervention and one week post intervention period
Secondary outcomes:
measure: To assess the change in cognitive performance associated with transcranial photobiomodulation
timeFrame: Assessed immediately before and immediately after intervention.
measure: To assess the change in cognitive performance associated with transcranial photobiomodulation.
timeFrame: Assessed immediately before and immediately after intervention
measure: To assess the change in cognitive performance associated with a sham control condition.
timeFrame: Assessed immediately before and immediately after intervention.
measure: To assess the change in cognitive performance associated with a sham control condition.
timeFrame: Assessed immediately before and immediately after intervention
measure: To measure changes in cerebrovascular oxygenation (oxygenated and deoxygenated hemoglobin) following transcranial photobiomodulation.
timeFrame: Assessed immediately before and immediately after intervention.
measure: To measure changes in cerebrovascular oxygenation (oxygenated and deoxygenated hemoglobin) following a sham control condition.
timeFrame: Assessed immediately before and immediately after intervention.
Other outcomes:
Locations:
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Andrew Heitzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: