Monitoring brain health in children with Sickle Cell Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to monitor the effects of Sickle Cell Disease (SCD) on cerebral hemodynamics in children aged 8-18 using advanced imaging techniques. It will utilize quantitative magnetic resonance imaging (MRI) and near-infrared spectroscopy (NIRS) to assess cerebral blood flow, oxygen extraction, and endothelial function. By identifying biomarkers for when intervention is necessary, the study seeks to improve treatment outcomes for SCD patients. The study includes healthy controls and various groups of SCD patients based on their treatment history.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Group 1 (healthy controls):

* Children ages 8-18 without SCD

Group 2 (SCD patients without treatment):

* SCD patients ages 8-18 who:

  * have not undergone gene therapy or a bone marrow transplant
  * are not receiving chronic transfusions
  * have not received a blood transfusion in the past 3 months

Group 3 (SCD patients who have undergone gene therapy):

* SCD patients ages 8-18 who have had gene therapy at least one month prior to enrollment

Group 4 (SCD patients who have chronic transfusions):

* SCD patients ages 8-18 who receive chronic transfusions

Exclusion Criteria:

* Electrical implants such as cardiac pacemakers or perfusion pumps;
* Ferromagnetic implants such as aneurysm clips, surgical clips, prosthesis, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants;
* Ferromagnetic objects such as jewelry or metal clips;
* Women of childbearing age who are seeking to become pregnant, who are breastfeeding, or who suspect they may be pregnant;
* Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions;
* Any greater than normal potential for cardiac arrest;
* Subjects requiring sedation for MRI

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Ellen Grant, MD — Boston Children's Hospital
• Study coordinator: Ellen Grant, MD
• Email: Ellen.Grant@childrens.harvard.edu
• Phone: 857-218-5111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cerebrovascular Reactivity Testing with HD-DOT in Sickle Cell Patients

  This study tests whether high-density diffuse optical tomography can measure brain blood flow and oxygen use in people with sickle cell disease, to see how these signals relate to stroke risk.

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• Adapting and testing PEN-Plus in Zambian primary care

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• Newborn Sickle Cell Screening in Mozambique

  We’re testing a three-part plan to help babies in Mozambique get diagnosed early for sickle cell disease and start care quickly.

  Recruiting St. Jude Children's Research Hospital · Nhamatanda, Sofala · NCT07719972

• Optimizing Hydroxyurea in Children with Sickle Cell in Africa

  This study tests whether raising hydroxyurea to a maximum tolerated dose is safe and beneficial for Ugandan children with sickle cell anemia already taking a fixed daily dose.

  Recruiting Phase 1/2 Children's Hospital Medical Center, Cincinnati · Kampala · NCT07708714

• Hematopoietic stem cell editing to treat sickle cell disease

  This study tests whether a patient’s own blood stem cells can be edited to remove the sickle cell triggering gene and then returned to the patient.

  Recruiting Phase 1 Boston Children's Hospital · Boston, Massachusetts · NCT07708350

• Virtual reality options to help with VOC pain in adults with SCD

  This study tests whether headset-based virtual reality can help reduce pain for adults with sickle cell disease during vaso-occlusive crises treated in an infusion center.

  Recruiting University of Maryland, Baltimore · Baltimore, Maryland · NCT07674277

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.