Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease
PHOTOSCAN
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2024
CompletedFirst Posted
Study publicly available on registry
January 28, 2025
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
April 23, 2026
April 1, 2026
1.7 years
December 12, 2024
April 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
Through study completion of all enrolled participants, estimated to be 3 years
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.
Immediately post intervention period
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.
Immediately post intervention period
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.
Immediately post intervention period
Assess caregiver-reported ratings of acceptability.
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.
Immediately post intervention period
Evaluate the frequency and nature of side effects associated with transcranial photobiomodulation.
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.
Immediately before intervention, immediately after intervention and one week post intervention period.
Evaluate the frequency and nature of side effects associated with transcranial photobiomodulation.
Descriptive statistics of self-report ratings on the Visual Analog Pain Scale will be reported.
Immediately before intervention, immediately after intervention and one week post intervention period
Secondary Outcomes (6)
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 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.
- +1 more secondary outcomes
Study Arms (4)
SCD Genotype SS/SB0; Age 8-12 Years
ACTIVE COMPARATORTranscranial photobiomodulation (TPBM), a light-based treatment using a fNIRS headset to capture changes in cerebral hemodynamics in the prefrontal cortex associated with (TPBM).
SCD Genotype - SS/SB0; Age 13-17 Years
ACTIVE COMPARATORTranscranial photobiomodulation (TPBM), a light-based treatment using a fNIRS headset to capture changes in cerebral hemodynamics in the prefrontal cortex associated with (TPBM).
SCD Genotype - SC/SB+; Age 8-12 Years
SHAM COMPARATORSham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.
SCD Genotype - SC/SB+; Age 13-17 Years
SHAM COMPARATORSham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.
Interventions
Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.
CytonBrite, 1064nm LED
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Heitzer, PhD
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Research participants will be told of their assigned group (sham control or intervention) after all study procedures are completed.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2024
First Posted
January 28, 2025
Study Start
April 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2029
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the time of article publication.
- Access Criteria
- Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the ClinicalTrials.gov (CTG) website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.