Ignite Creation Date:
2024-05-06 @ 5:54 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05473429
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2022-07-23
Brief Title:
Characterization of Nociception Phenotype in Individuals With Intellectual Disability
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Characterization of the Nociception Phenotype in Individuals With Intellectual Disability
Status:
RECRUITING
Status Verified Date:
2024-09-03
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
People with intellectual disability ID often have physical disabilities as well These physical problems can affect their bones muscles nerves and gastrointestinal tracts All of these issues can also cause pain Yet little research has been done on pain in people with ID
Objective
To compare brain responses to unpleasant stimuli in people with and without ID
Eligibility
People aged 8 to 30 years diagnosed with an ID Healthy volunteers without an ID are also needed
Design
The study requires only 1 visit of up to 4 hours Participants with ID may come for up to 5 shorter visits instead
Participants will take a test to measure their level of ID They will have a physical exam
Both groups will answer questions about pain and how their bodies react to it They will answer questions about how they respond to things they see feel hear smell and taste They will answer questions about their social behaviors Caregivers may answer questions if the participant cannot
Both groups will have a test to measure their brain activity Participants will wear a special cap like a swim cap with sensors and wires Sensors to examine the heart will be placed on the skin of their chest with stickers An elastic band will be placed around the middle of their body to measure how fast they are breathing Sensors to measure sweat will be placed on two fingers
Participants will have heat cold brushing and mild electrical stimuli to different parts of their body Participants will rank how each stimulus feels using a scale with numbers or a scale with faces
People with intellectual disability ID often have physical disabilities as well These physical problems can affect their bones muscles nerves and gastrointestinal tracts All of these issues can also cause pain Yet little research has been done on pain in people with ID
Objective
To compare brain responses to unpleasant stimuli in people with and without ID
Eligibility
People aged 8 to 30 years diagnosed with an ID Healthy volunteers without an ID are also needed
Design
The study requires only 1 visit of up to 4 hours Participants with ID may come for up to 5 shorter visits instead
Participants will take a test to measure their level of ID They will have a physical exam
Both groups will answer questions about pain and how their bodies react to it They will answer questions about how they respond to things they see feel hear smell and taste They will answer questions about their social behaviors Caregivers may answer questions if the participant cannot
Both groups will have a test to measure their brain activity Participants will wear a special cap like a swim cap with sensors and wires Sensors to examine the heart will be placed on the skin of their chest with stickers An elastic band will be placed around the middle of their body to measure how fast they are breathing Sensors to measure sweat will be placed on two fingers
Participants will have heat cold brushing and mild electrical stimuli to different parts of their body Participants will rank how each stimulus feels using a scale with numbers or a scale with faces
Detailed Description:
STUDY DESCRIPTION
The study aims to evaluate the somatosensory response to innocuous and noxious stimuli in individuals with Intellectual Disability ID compared to healthy controls
OBJECTIVES
Primary Objective
To characterize brain activation patterns using electroencephalography EEG and cerebral functional-near-infrared spectroscopy fNIRS in response to innocuous and noxious stimulation in individuals with ID ages 8-30 years compared with the brain activation pattern observed in healthy controls
We hypothesize that compared to healthy controls individuals with ID will present decreases in oxygenated hemoglobin measured by fNIRS in pain responsive regions eg secondary somatosensory cortex in response to standardized noxious stimuli heat cold and electrical In addition individuals with ID will also present smaller suppression of oscillation in alpha and beta frequencies measured by EEG at central sites in response to these stimuli
Exploratory Objective
To determine the relationship between brain activation patterns to innocuous and noxious stimuli with physiological and behavioral responses to the same stimuli in individuals with ID We hypothesize that decreased oxygenated hemoglobin in response to noxious stimuli in the secondary somatosensory cortex as well as smaller suppression of oscillations in alpha and beta frequencies at central sites in individuals with ID will correlate with changes in heart rate galvanic skin response and pupil dilation In addition we hypothesize that decreased oxygenated hemoglobin to noxious thermal and electrical stimuli in the secondary somatosensory cortex as well as smaller suppression of oscillations in alpha and beta frequencies will also be associated with behavioral observations eg vocal social and changes in facial body and extremities activity
ENDPOINTS
Primary Endpoints
1 fNIRS response to innocuous and noxious stimuli oxygenated and deoxygenated hemoglobin concentration measured in the secondary somatosensory cortex
2 EEG response to innocuous and noxious stimuli Alpha and beta oscillations measured at central sites C3 and C4
3 Physiological responses to innocuous and noxious stimulation heart rate respiratory rate galvanic skin response and pupillary changes
4 Behavioral responses to noxious stimulation eg vocal social and changes in facial body and extremities activity
The study aims to evaluate the somatosensory response to innocuous and noxious stimuli in individuals with Intellectual Disability ID compared to healthy controls
OBJECTIVES
Primary Objective
To characterize brain activation patterns using electroencephalography EEG and cerebral functional-near-infrared spectroscopy fNIRS in response to innocuous and noxious stimulation in individuals with ID ages 8-30 years compared with the brain activation pattern observed in healthy controls
We hypothesize that compared to healthy controls individuals with ID will present decreases in oxygenated hemoglobin measured by fNIRS in pain responsive regions eg secondary somatosensory cortex in response to standardized noxious stimuli heat cold and electrical In addition individuals with ID will also present smaller suppression of oscillation in alpha and beta frequencies measured by EEG at central sites in response to these stimuli
Exploratory Objective
To determine the relationship between brain activation patterns to innocuous and noxious stimuli with physiological and behavioral responses to the same stimuli in individuals with ID We hypothesize that decreased oxygenated hemoglobin in response to noxious stimuli in the secondary somatosensory cortex as well as smaller suppression of oscillations in alpha and beta frequencies at central sites in individuals with ID will correlate with changes in heart rate galvanic skin response and pupil dilation In addition we hypothesize that decreased oxygenated hemoglobin to noxious thermal and electrical stimuli in the secondary somatosensory cortex as well as smaller suppression of oscillations in alpha and beta frequencies will also be associated with behavioral observations eg vocal social and changes in facial body and extremities activity
ENDPOINTS
Primary Endpoints
1 fNIRS response to innocuous and noxious stimuli oxygenated and deoxygenated hemoglobin concentration measured in the secondary somatosensory cortex
2 EEG response to innocuous and noxious stimuli Alpha and beta oscillations measured at central sites C3 and C4
3 Physiological responses to innocuous and noxious stimulation heart rate respiratory rate galvanic skin response and pupillary changes
4 Behavioral responses to noxious stimulation eg vocal social and changes in facial body and extremities activity
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 |
|---|---|---|---|
| 000417-CC | None | None | None |