Sickle Cell DiseasePHOTOSCANNCT06797583
Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease
A study testing Active Transcranial Photobiomodulation (TPBM) in people with Sickle Cell Disease, run by St. Jude Children's Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Active Transcranial Photobiomodulation (TPBM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read more
- 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.
Read the 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Active Transcranial Photobiomodulation (TPBM), Sham Transcranial photobiomodulation (TPBM)
- Keywords
- Sickle Cell Disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Photobiomodulation (TPBM)Device
CytonBrite, 1064nm LED
Sham Transcranial photobiomodulation (TPBM)Device
Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.
| Study group | Role | What they receive |
|---|---|---|
| SCD Genotype SS/SB0; Age 8-12 Years | Active comparator | Transcranial photobiomodulation (TPBM), a light-based treatment using a fNIRS headset to capture changes in cerebral hemodynamics in the prefrontal cortex associated with (TPBM). Receives: Device: Active Transcranial Photobiomodulation (TPBM) |
| SCD Genotype - SS/SB0; Age 13-17 Years | Active comparator | Transcranial photobiomodulation (TPBM), a light-based treatment using a fNIRS headset to capture changes in cerebral hemodynamics in the prefrontal cortex associated with (TPBM). Receives: Device: Active Transcranial Photobiomodulation (TPBM) |
| SCD Genotype - SC/SB+; Age 8-12 Years | Sham comparator | Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization. Receives: Device: Sham Transcranial photobiomodulation (TPBM) |
| SCD Genotype - SC/SB+; Age 13-17 Years | Sham comparator | Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization. Receives: Device: Sham Transcranial photobiomodulation (TPBM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Assessed immediately before and immediately after intervention.
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.
Measured: Assessed immediately before and immediately after intervention
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.
Measured: Assessed immediately before and immediately after intervention.
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.
Measured: Assessed immediately before and immediately after intervention
To measure changes in cerebrovascular oxygenation (oxygenated and deoxygenated hemoglobin) following transcranial photobiomodulation.
Means will be calculated for HbO2 and Hb levels in each group. Hypothesis tests will be conducted to determine if there are statistically significant differences in HbO2 and Hb levels between the treatment and control groups. Appropriate parametric or non-parametric tests will be utilized based on data distribution and assumptions. The effect sizes (e.g., Cohen's d) will also be calculated to quantify the magnitude of the differences observed.
Measured: Assessed immediately before and immediately after intervention.
To measure changes in cerebrovascular oxygenation (oxygenated and deoxygenated hemoglobin) following a sham control condition.
Meanswill be calculated for HbO2 and Hb levels in each group. Hypothesis tests will be conducted to determine if there are statistically significant differences in HbO2 and Hb levels between the treatment and control groups. Appropriate parametric or non-parametric tests will be utilized based on data distribution and assumptions. The effect sizes (e.g., Cohen's d) will also be calculated to quantify the magnitude of the differences observed.
Measured: Assessed immediately before and immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study startNov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Heitzer, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797583
- Sponsor's protocol ID
- PHOTOSCAN
- Acronym
- PHOTOSCAN
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06797583
- Acronym / sponsor ID
- PHOTOSCAN / PHOTOSCAN
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| SCD Genotype SS/SB0; Age 8-12 Years | Active comparator | Device: Active Transcranial Photobiomodulation (TPBM)Transcranial 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 comparator | Device: Active Transcranial Photobiomodulation (TPBM)Transcranial 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 comparator | Device: Sham Transcranial photobiomodulation (TPBM)Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization. |
| SCD Genotype - SC/SB+; Age 13-17 Years | Sham comparator | Device: Sham Transcranial photobiomodulation (TPBM)Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Transcranial Photobiomodulation (TPBM)CytonBrite, 1064nm LED | Device | SCD Genotype - SS/SB0; Age 13-17 Years, SCD Genotype SS/SB0; Age 8-12 Years |
| Sham Transcranial photobiomodulation (TPBM)Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization. | Device | SCD Genotype - SC/SB+; Age 13-17 Years, SCD Genotype - SC/SB+; Age 8-12 Years |
Primary outcome
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Evaluate the frequency and nature of side effects associated with transcranial photobiomodulation.
Time frame: 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.
6 secondary outcomes
To assess the change in cognitive performance associated with transcranial photobiomodulation
Time frame: Assessed immediately before and immediately after intervention.
To assess the change in cognitive performance associated with transcranial photobiomodulation.
Time frame: Assessed immediately before and immediately after intervention
To assess the change in cognitive performance associated with a sham control condition.
Time frame: Assessed immediately before and immediately after intervention.
To assess the change in cognitive performance associated with a sham control condition.
Time frame: Assessed immediately before and immediately after intervention
To measure changes in cerebrovascular oxygenation (oxygenated and deoxygenated hemoglobin) following transcranial photobiomodulation.
Time frame: Assessed immediately before and immediately after intervention.
To measure changes in cerebrovascular oxygenation (oxygenated and deoxygenated hemoglobin) following a sham control condition.
Time frame: Assessed immediately before and immediately after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Heitzer, PhD principal investigator
St. Jude Children's Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Photobiomodulation (TPBM) in people with Sickle Cell Disease, run by St. Jude Children's Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew Heitzer, PhD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Through study completion of all enrolled participants, estimated to be 3 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.