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Completed
NCT05642221
Functional Near-Infrared Spectroscopy (fNIRS) Combined With Diffuse Correlation Spectroscopy (DCS) in Neurocognitive Disease as Compared to Healthy Neurotypical Controls
Conditions: Juvenile Neuronal Ceroid Lipofuscinosis, Smith-Lemli-Opitz Syndrome, Creatine Transporter Deficiency, Niemann-Pick Disease Type C1
Sex: All
Ages: 6 Months – 110 Years
Healthy volunteers: No
Enrollment: 73
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Location: National Institutes of Health Clinical Center Bethesda Maryland
Summary
Background:
Neurocognitive disorders affect how the brain uses oxygen. They may affect mental development in children. These disorders can be studied with imaging scans that use radiation; however, these methods are not ideal for research on children. Two technologies-functional near-infrared spectroscopy (fNIRS) and diffuse correlation spectroscopy (DCS)-use light to detect changes in brain activity. These methods are safer, and they can be used in a more relaxed setting. In this natural history study, researchers want to find out whether fNIRS and DCS can be a good way to study people with neurocognitive disorders.
Objective:
To find out whether fNIRS and DCS can be useful in measuring brain activity in people with neurocognitive disorders.
Eligibility:
People aged 6 months or older with neurocognitive disorders. These can include Niemann-Pick disease type C1 (NPC1); creatine transporter deficiency (CTD); Smith Lemli Opitz syndrome (SLOS); juvenile neuronal ceroid lipofuscinosis (CLN3 disease); and Pheland-McDermid (PMS) syndrome. Healthy volunteers are also needed.
Design:
Participants will have a physical exam. They will have tests of their memory and thinking.
Participants will sit in a quiet room for the fNIRS and DCS tests. A snug cap (like a cloth swim cap) will be placed on their head. The cap has lights and sensors. Another sensor will be placed on their forehead. Participants will perform tasks on a computer. This testing will take 45 to 60 minutes.
The tests will be repeated within 1 to 4 weeks. Participants will be asked to return for repeat tests 1 year later....
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
Source: ClinicalTrials.gov (NCT05642221). StuddyBuddy aggregates publicly available trial information.
