Ignite Creation Date:
2024-07-17 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472622
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-22
Brief Title:
Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06-28
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
The way the brain processes rewards and punishments may play a role in some disorders of the nervous system People with chronic overlapping pain conditions such as myalgic encephalomyelitischronic fatigue syndrome MECFS may have heightened responses to unpleasant punishing sensations Some of these conditions may also cause heightened responses to effort this is an unpleasant sensation felt during physical and mental exertion
Objective
To learn more about how the brain processes different unpleasant sensations
Eligibility
People aged 18 to 50 years with MECFS Healthy volunteers are also needed
Design
Participants will have 3 visits in 1 to 5 weeks
Visit 1 Participants may have a neurologic exam They will have a mock magnetic resonance imaging MRI scan They will lie on a bed in a wooden tube while they practice 2 tasks
Thermal pain rating A device that creates mild to moderate heat will be placed on one leg
Physical effort rating Participants will squeeze a plastic bar with different levels of force
Visit 2 Participants will have a real MRI scan They will lie on a table that slides into a large tube
Visit 3 Participants will have another MRI scan They will repeat the thermal pain and physical effort tasks while in the scanner Sensors will be placed on 1 arm to measure how the muscles function as they squeeze the bar
Their heart rate will be tested They will hold their finger against a camera lens for 1 minute They will do 2 other tasks 1 requires repeatedly pressing a key on a keyboard and the other requires squeezing a bar
The way the brain processes rewards and punishments may play a role in some disorders of the nervous system People with chronic overlapping pain conditions such as myalgic encephalomyelitischronic fatigue syndrome MECFS may have heightened responses to unpleasant punishing sensations Some of these conditions may also cause heightened responses to effort this is an unpleasant sensation felt during physical and mental exertion
Objective
To learn more about how the brain processes different unpleasant sensations
Eligibility
People aged 18 to 50 years with MECFS Healthy volunteers are also needed
Design
Participants will have 3 visits in 1 to 5 weeks
Visit 1 Participants may have a neurologic exam They will have a mock magnetic resonance imaging MRI scan They will lie on a bed in a wooden tube while they practice 2 tasks
Thermal pain rating A device that creates mild to moderate heat will be placed on one leg
Physical effort rating Participants will squeeze a plastic bar with different levels of force
Visit 2 Participants will have a real MRI scan They will lie on a table that slides into a large tube
Visit 3 Participants will have another MRI scan They will repeat the thermal pain and physical effort tasks while in the scanner Sensors will be placed on 1 arm to measure how the muscles function as they squeeze the bar
Their heart rate will be tested They will hold their finger against a camera lens for 1 minute They will do 2 other tasks 1 requires repeatedly pressing a key on a keyboard and the other requires squeezing a bar
Detailed Description:
Study Description
This protocol will examine the associations between brain activation and the subjective unpleasantness associated with pain and physical effort in healthy individuals We have developed two behavioral tasks for administration during neuroimaging a Thermal Pain Rating task and a Physical Effort Rating task which will allow us to identify brain regions in which activity is associated with the unpleasantness of these experiences We hypothesize that the unpleasantness of the experiences will be associated with activity in a recently identified network of brain regions thought to be involved in computing subjective value known as the subjective valuation network SVN
Objectives
Primary Objectives
1 Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain
2 Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort
Endpoints
Primary Endpoints
1 SVN regions in which activity is significantly associated with unpleasantness of pain
2 SVN regions in which activity is significantly associated with unpleasantness of physical effort
This protocol will examine the associations between brain activation and the subjective unpleasantness associated with pain and physical effort in healthy individuals We have developed two behavioral tasks for administration during neuroimaging a Thermal Pain Rating task and a Physical Effort Rating task which will allow us to identify brain regions in which activity is associated with the unpleasantness of these experiences We hypothesize that the unpleasantness of the experiences will be associated with activity in a recently identified network of brain regions thought to be involved in computing subjective value known as the subjective valuation network SVN
Objectives
Primary Objectives
1 Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of pain
2 Determine which regions of the SVN are specifically involved in the subjective experience of unpleasantness associated with sensations of physical effort
Endpoints
Primary Endpoints
1 SVN regions in which activity is significantly associated with unpleasantness of pain
2 SVN regions in which activity is significantly associated with unpleasantness of physical effort
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 |
|---|---|---|---|
| 001925-N | None | None | None |