Transcranial Photobiomodulation Treatment in Patients With Sickle Cell Disease

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06797583
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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 Details

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.

Key Dates

First listed
Jan 28, 2025
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: 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).
  • Active Comparator: 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).
  • Sham Comparator: SCD Genotype - SC/SB+; Age 8-12 Years
    Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.
  • Sham Comparator: SCD Genotype - SC/SB+; Age 13-17 Years
    Sham condition using a randomized block design involving 2 (TPBM): 1(sham) randomization.

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 ]

Central Contacts

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