Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03937778
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2019-05-03
Brief Title:
Sensory Afferents for Deep Pressure Sensation
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Sensory Afferents for Deep Pressure Sensation
Status:
COMPLETED
Status Verified Date:
2021-09
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
Much is known about how people perceive light touch temperature and pain But less is known about how deep pressure is perceived Deep pressure is an important part of many touch therapies like massage therapy Researchers want to learn more to help people with chronic pain and other disorders
Objective
To find out which sensory nerve fibers are involved in feeling the sensation of deep pressure
Eligibility
Healthy people ages 18 50 enrolled in study number 16-AT-0077
Design
Participants will be screened under study number 16-AT-0077
Participants will have 1 visit that lasts about 2 hours
Participants will have a brief medical interview They will have a urine test
Participants will have ischemic nerve block on 1 arm A blood pressure cuff will be inflated until the arm is numb for up to an hour
Participants will have tests to see how they perceive different sensations They will rate gentle brushing on the hands and forearms They will rate gentle pressure squeezing from a hand massager on the hands and forearms
Participants will receive other sensations such as vibration cool warm pinprick without piercing the skin finger movement and pressure They will be asked to rate or respond to the sensations They will be asked to rate any pain or discomfort from the nerve block on an ongoing basis
Much is known about how people perceive light touch temperature and pain But less is known about how deep pressure is perceived Deep pressure is an important part of many touch therapies like massage therapy Researchers want to learn more to help people with chronic pain and other disorders
Objective
To find out which sensory nerve fibers are involved in feeling the sensation of deep pressure
Eligibility
Healthy people ages 18 50 enrolled in study number 16-AT-0077
Design
Participants will be screened under study number 16-AT-0077
Participants will have 1 visit that lasts about 2 hours
Participants will have a brief medical interview They will have a urine test
Participants will have ischemic nerve block on 1 arm A blood pressure cuff will be inflated until the arm is numb for up to an hour
Participants will have tests to see how they perceive different sensations They will rate gentle brushing on the hands and forearms They will rate gentle pressure squeezing from a hand massager on the hands and forearms
Participants will receive other sensations such as vibration cool warm pinprick without piercing the skin finger movement and pressure They will be asked to rate or respond to the sensations They will be asked to rate any pain or discomfort from the nerve block on an ongoing basis
Detailed Description:
Objective
The sensory basis of non-painful deep pressure sensation is not known We recently found that innocuous pressure sensation is eliminated in rare sensory neuronopathy patients with a specific loss of A-beta fibers strongly suggesting that A-beta fibers underlie the ability to sense deep pressure In addition we and others have shown that deep pressure touch observed in hugs and massage frequently conveys a sense of pleasantness The current study aims to examine the role of A-beta fibers in the perception of deep pressure touch including both its intensity and the pleasant affect it often elicits This study constitutes the second study of the K99 phase of a K99R00 grant application awarded to Dr Laura Case by National Center for Complementary and Integrative Health NCCIH
Study Population
Up to 24 healthy participants will be enrolled in the study with a goal of 12 completers Participants will be invited based on previous screening and participation in our studies
Design Participants will undergo an ischemic-compression block Sensory stimuli will be administered at frequent intervals to capture the loss of sensation related to A fibers as the block progresses Before and after A-beta-associated sensations have been lost the perception of deep pressure will be tested Participants will rate the intensity and pleasantness of the pressure Ratings of pain and discomfort will be collected throughout the study session
Outcome measures Primary outcome Rating of intensity of deep pressure on the blocked arm before versus after loss of A-beta sensation compared to ratings on the unblocked arm
Secondary outcomes 1 Rating of pleasantness of deep pressure on the blocked arm after loss of A-beta sensation compared to ratings on the unblocked arm 2 Ratings of intensity and pleasantness of gentle brushing on the blocked arm after loss of A-beta sensation compared to ratings on the unblocked arm
The sensory basis of non-painful deep pressure sensation is not known We recently found that innocuous pressure sensation is eliminated in rare sensory neuronopathy patients with a specific loss of A-beta fibers strongly suggesting that A-beta fibers underlie the ability to sense deep pressure In addition we and others have shown that deep pressure touch observed in hugs and massage frequently conveys a sense of pleasantness The current study aims to examine the role of A-beta fibers in the perception of deep pressure touch including both its intensity and the pleasant affect it often elicits This study constitutes the second study of the K99 phase of a K99R00 grant application awarded to Dr Laura Case by National Center for Complementary and Integrative Health NCCIH
Study Population
Up to 24 healthy participants will be enrolled in the study with a goal of 12 completers Participants will be invited based on previous screening and participation in our studies
Design Participants will undergo an ischemic-compression block Sensory stimuli will be administered at frequent intervals to capture the loss of sensation related to A fibers as the block progresses Before and after A-beta-associated sensations have been lost the perception of deep pressure will be tested Participants will rate the intensity and pleasantness of the pressure Ratings of pain and discomfort will be collected throughout the study session
Outcome measures Primary outcome Rating of intensity of deep pressure on the blocked arm before versus after loss of A-beta sensation compared to ratings on the unblocked arm
Secondary outcomes 1 Rating of pleasantness of deep pressure on the blocked arm after loss of A-beta sensation compared to ratings on the unblocked arm 2 Ratings of intensity and pleasantness of gentle brushing on the blocked arm after loss of A-beta sensation compared to ratings on the unblocked arm
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 |
|---|---|---|---|
| 19-AT-0089 | None | None | None |