Trials
Search / Trial NCT05642221

Functional Near-Infrared Spectroscopy (fNIRS) Combined With Diffuse Correlation Spectroscopy (DCS) in Neurocognitive Disease as Compared to Healthy Neurotypical Controls

Launched by EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) · Dec 7, 2022

Trial Information

Current as of February 05, 2025

Recruiting

Keywords

Brain Hypometabolism Cerebral Blood Flow Portable Brain Imaging Cerebral O2 Changes Neurocognitive Disorders Natural History

ClinConnect Summary

This clinical trial is studying two new, safe imaging techniques called functional near-infrared spectroscopy (fNIRS) and diffuse correlation spectroscopy (DCS) to see how well they can measure brain activity in children with neurocognitive disorders. These disorders can affect how the brain uses oxygen, which can impact mental development in kids. The researchers want to find out if these light-based methods are effective for understanding brain function in children with conditions like Niemann-Pick disease type C1, creatine transporter deficiency, Smith-Lemli-Opitz syndrome, and juvenile neuronal ceroid lipofuscinosis, as well as in healthy children.

To participate, individuals need to be at least 6 months old and speak English at home. Participants will undergo a physical exam and simple memory and thinking tests in a quiet room while wearing a snug cap with lights and sensors. The testing will take about 45 to 60 minutes and will be repeated a few weeks later, and again a year later. This study aims to help researchers learn more about these brain imaging techniques and how they may benefit children with neurocognitive disorders.

Gender

ALL

Eligibility criteria

  • * INCLUSION CRITERIA:
  • * For both study populations (Affected and Typically Developing group):
  • Male or female, aged 6 months and up
  • English is the primary language spoken at home
  • * For study population (Affected group):
  • --Neurocognitive-related conditions including SLOS, CLN3, CTD, NPC and PMS.
  • * For controls (Typically Developing Group):
  • In good general health as determined by medical history and physical exam
  • EXCLUSION CRITERIA:
  • * For both study populations (Affected and Typically Developing group):
  • Any condition that may affect placement of the fNIRS-DCS
  • Past or present vascular disease
  • Traumatic loss of consciousness in the last year
  • Any condition which, in the opinion of the investigator, increases risk of participation or affects adherence to the protocol
  • * For controls (Typically Developing Group):
  • Known or suspected cognitive impairment
  • Known history of MRI abnormality
  • Current use of psychotropic medications

Trial Officials

Samar N Rahhal, M.D.

Principal Investigator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

About Eunice Kennedy Shriver National Institute Of Child Health And Human Development (Nichd)

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is a prominent research agency within the National Institutes of Health (NIH), dedicated to advancing the health and well-being of children, families, and individuals across the lifespan. NICHD supports a wide range of clinical trials and research initiatives aimed at understanding the complex biological, behavioral, and environmental factors that influence human development and health. By fostering innovative research and facilitating collaboration among scientists, healthcare professionals, and communities, NICHD plays a vital role in translating scientific discoveries into effective interventions and policies that enhance child health, reproductive health, and the prevention of diseases.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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