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Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease

NCT06797583 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Active Transcranial Photobiomodulation (TPBM)

CytonBrite, 1064nm LED

DEVICE

Sham Transcranial photobiomodulation (TPBM)

Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.

Sponsors & Collaborators

Principal Investigators

  • Andrew Heitzer, PhD · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797583 on ClinicalTrials.gov