Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05642221
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2022-12-07
Brief Title:
Functional Near-Infrared Spectroscopy fNIRS Combined With Diffuse Correlation Spectroscopy DCS in Neurocognitive Disease as Compared to Healthy Neurotypical Controls
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-09-16
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
Study Description
Brain hypometabolism has been observed in neurologic conditions These data were obtained using modalities that involved radiation exposure and were not easily amenable to being combined with performance of functional tasks Functional near-infrared spectroscopy fNIRS and Diffusion Correlation Spectroscopy DCS are noninvasive easy-to-use and portable brain imaging technology that enable studies of metabolic parameters and their alterations with task performance in neurotypical and neurocognitively affected individuals Specifically it enables the study of brain oxygen utilization which likely correlates with brain metabolism We are proposing a pilot study of the use of fNIRS and DCS in neurocognitive disorders that have been extensively followed in our groups 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 We want to compare findings in these populations to neurotypical healthy controls
Objectives
The primary objective of this pilot study is to determine the feasibility of fNIRS-DCS in individuals with neurocognitive-related disorders
The secondary objectives of this study are
1 To collect pilot data on individuals with neurocognitive disorders to determine the patterns of cerebral oxygen consumption as measured by fNIRS and DCS
2 To compare cerebral oxygen consumption changes from resting state in affected individuals versus age-appropriate healthy volunteers
An exploratory objective is to correlate cerebral oxygen consumption changes from resting state in affected individuals to other measures of disease state eg neuropsychological assessment disease-specific severity rating scales Another exploratory objective is to examine test-retest reliability of our fNIRS-DCS measures at rest and during specific tasks in both affected individuals and healthy controls
Endpoints
Primary endpoints
Adverse events number of individuals who complete study
Secondary endpoints
Patterns of cerebral oxygen consumption and blood flow in neurocognitive disorders compared to healthy controls
Brain hypometabolism has been observed in neurologic conditions These data were obtained using modalities that involved radiation exposure and were not easily amenable to being combined with performance of functional tasks Functional near-infrared spectroscopy fNIRS and Diffusion Correlation Spectroscopy DCS are noninvasive easy-to-use and portable brain imaging technology that enable studies of metabolic parameters and their alterations with task performance in neurotypical and neurocognitively affected individuals Specifically it enables the study of brain oxygen utilization which likely correlates with brain metabolism We are proposing a pilot study of the use of fNIRS and DCS in neurocognitive disorders that have been extensively followed in our groups 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 We want to compare findings in these populations to neurotypical healthy controls
Objectives
The primary objective of this pilot study is to determine the feasibility of fNIRS-DCS in individuals with neurocognitive-related disorders
The secondary objectives of this study are
1 To collect pilot data on individuals with neurocognitive disorders to determine the patterns of cerebral oxygen consumption as measured by fNIRS and DCS
2 To compare cerebral oxygen consumption changes from resting state in affected individuals versus age-appropriate healthy volunteers
An exploratory objective is to correlate cerebral oxygen consumption changes from resting state in affected individuals to other measures of disease state eg neuropsychological assessment disease-specific severity rating scales Another exploratory objective is to examine test-retest reliability of our fNIRS-DCS measures at rest and during specific tasks in both affected individuals and healthy controls
Endpoints
Primary endpoints
Adverse events number of individuals who complete study
Secondary endpoints
Patterns of cerebral oxygen consumption and blood flow in neurocognitive disorders compared to healthy controls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000862-CH | None | None | None |