Protocol Details
Pilot Study of the Use of Functional Near-Infrared Spectroscopy (fNIRS) Combined with Diffuse Correlation Spectroscopy (DCS) in Neurocognitive Disease as Compared to Healthy Neurotypical Controls
This study is NOT currently recruiting participants.
Summary
Number | 000862-CH |
Sponsoring Institute | National Institute of Child Health and Human Development (NICHD) |
Recruitment Detail | Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 6 mo
Max Age: 110 Years |
Referral Letter Required | No |
Population Exclusion(s) | Non-English Speaking |
Keywords | Brain Hypometabolism;
Cerebral Blood Flow;
Portable Brain Imaging;
Cerebral O2 Changes;
Neurocognitive Disorders;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Juvenile Neuronal Ceroid Lipofuscinosis;
Smith-Lemli-Opitz Syndrome;
Creatine Transporter Deficiency;
Niemann-Pick Disease Type C1 |
Investigational Drug(s) | None |
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Institute of Child Health and Human Development |
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
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
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT05642221