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出境医 / 临床实验 / Sensory Afferents for Deep Pressure Sensation

Sensory Afferents for Deep Pressure Sensation

Study Description
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 completely numb for up to an hour.

Participants will have tests to see how they perceive different sensations. They will rate gentle brushing on the arms. They will rate gentle pressure squeezing from a compression sleeve on the arms.

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.


Condition or disease Intervention/treatment Phase
Normal Physiology Behavioral: Deep pressure block Not Applicable

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 K99/R00 grant application awarded to Dr. Laura Case by 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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Sensory Afferents for Deep Pressure Sensation
Actual Study Start Date : June 20, 2019
Actual Primary Completion Date : November 17, 2020
Actual Study Completion Date : November 17, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: 1/Blocked Arm
Arm with applied deep pressure block
Behavioral: Deep pressure block
Apply deep pressure block by using blood pressure cuff.

Outcome Measures
Primary Outcome Measures :
  1. Rating of intensity of deep pressure [ Time Frame: 1 visit ]
    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 Outcome Measures :
  1. Rating of pleasantness of deep pressure [ Time Frame: 1 visit ]
    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 [ Time Frame: 1 visit ]
    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

All subjects must be:

  • Between 18 and 50 years old.
  • Fluent in English.
  • Able to provide written informed consent.
  • Enrolled in 16-AT-0077, Clinical and Scientific Assessment of Pain and Painful Disorders

EXCLUSION CRITERIA:

  • Unable to comply with study procedures.
  • Have used recreational drugs in the past 30 days.
  • Pregnancy or breastfeeding.
  • Congenital upper limb deficiency or amputation.
  • Peripheral neuropathy, dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous four weeks that might influence cutaneous sensibility.
  • Current chronic pain condition or has had chronic pain in the past year (painful condition lasting more than six months), including ongoing treatment with medications for neuropathic pain (e.g. gabapentin, tricyclic antidepressants, pregabalin, tramadol).
  • Major medical condition, such as kidney, liver, cardiovascular (including blood clots, hypertension, preexisting cardiac arrhythmia, lymphadenopathy), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes) or Raynaud s disease.
  • Personal history or first-degree family history of blood clots or clotting and circulatory disorders
  • History of a seizures or first-degree family member with a seizure disorder
  • High (>140/90) or low (<90/60) blood pressure
  • Current and untreated diagnosis of major depression, post-traumatic stress syndrome, bipolar disorder, psychosis, anxiety or panic disorder, alcohol or substance use disorders
  • History of fainting with blood draws
  • Any medical counter-indications to the nerve blocks.
  • Participant s arm unable to fit in inflated arm blood pressure cuff
  • Participant has taken any pain medication other than an over-the-counter NSAIDs or acetaminophen within the last month or for more than one month on a continual basis within last six months.
  • Used topical pain-relieving creams in the testing area within 24 hours of testing or non-steroidal anti-inflammatory drugs (NSAIDS), (e.g. aspirin, ibuprofen, acetaminophen, or naproxen) within 3 days of testing
  • Recent use of medications that increase risk of seizures (e.g. antidepressant Wellbutrin or antipsychotic Haldol)
  • NIH employees who are subordinates, relatives, or co-workers of the investigators, or NCCIH DIR employees.

EXCLUSION CRITERIA FOR INDIVIDUAL STUDY SESSION:

  • Shows signs of alcohol withdrawal syndrome, or has behavioral signs of intoxication: will be excluded immediately and not have the possibility to reschedule their session.
  • Used topical pain-relieving creams in the testing area (e.g. methylsalicylate, capsaicin) within 24 hours of testing or used non-steroidal anti-inflammatory drugs (NSAIDS, e.g. aspirin, ibuprofen), acetaminophen, or naproxen within 3 days of testing.
Contacts and Locations

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Layout table for investigator information
Principal Investigator: Alexander T Chesler, Ph.D. National Center for Complementary and Integrative Health (NCCIH)
Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 6, 2019
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE June 20, 2019
Actual Primary Completion Date November 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
Rating of intensity of deep pressure [ Time Frame: 1 visit ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2019)
  • Rating of pleasantness of deep pressure [ Time Frame: 1 visit ]
    Rating of pleasantness of deep pressure on the blocked arm after loss of A-beta sensation, compared to ratings on the unblocked arm
  • Ratings of intensity and pleasantness [ Time Frame: 1 visit ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sensory Afferents for Deep Pressure Sensation
Official Title  ICMJE Sensory Afferents for Deep Pressure Sensation
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 completely numb for up to an hour.

Participants will have tests to see how they perceive different sensations. They will rate gentle brushing on the arms. They will rate gentle pressure squeezing from a compression sleeve on the arms.

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 K99/R00 grant application awarded to Dr. Laura Case by 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Normal Physiology
Intervention  ICMJE Behavioral: Deep pressure block
Apply deep pressure block by using blood pressure cuff.
Study Arms  ICMJE Experimental: 1/Blocked Arm
Arm with applied deep pressure block
Intervention: Behavioral: Deep pressure block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2020)
4
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2019)
24
Actual Study Completion Date  ICMJE November 17, 2020
Actual Primary Completion Date November 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • INCLUSION CRITERIA:

All subjects must be:

  • Between 18 and 50 years old.
  • Fluent in English.
  • Able to provide written informed consent.
  • Enrolled in 16-AT-0077, Clinical and Scientific Assessment of Pain and Painful Disorders

EXCLUSION CRITERIA:

  • Unable to comply with study procedures.
  • Have used recreational drugs in the past 30 days.
  • Pregnancy or breastfeeding.
  • Congenital upper limb deficiency or amputation.
  • Peripheral neuropathy, dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous four weeks that might influence cutaneous sensibility.
  • Current chronic pain condition or has had chronic pain in the past year (painful condition lasting more than six months), including ongoing treatment with medications for neuropathic pain (e.g. gabapentin, tricyclic antidepressants, pregabalin, tramadol).
  • Major medical condition, such as kidney, liver, cardiovascular (including blood clots, hypertension, preexisting cardiac arrhythmia, lymphadenopathy), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes) or Raynaud s disease.
  • Personal history or first-degree family history of blood clots or clotting and circulatory disorders
  • History of a seizures or first-degree family member with a seizure disorder
  • High (>140/90) or low (<90/60) blood pressure
  • Current and untreated diagnosis of major depression, post-traumatic stress syndrome, bipolar disorder, psychosis, anxiety or panic disorder, alcohol or substance use disorders
  • History of fainting with blood draws
  • Any medical counter-indications to the nerve blocks.
  • Participant s arm unable to fit in inflated arm blood pressure cuff
  • Participant has taken any pain medication other than an over-the-counter NSAIDs or acetaminophen within the last month or for more than one month on a continual basis within last six months.
  • Used topical pain-relieving creams in the testing area within 24 hours of testing or non-steroidal anti-inflammatory drugs (NSAIDS), (e.g. aspirin, ibuprofen, acetaminophen, or naproxen) within 3 days of testing
  • Recent use of medications that increase risk of seizures (e.g. antidepressant Wellbutrin or antipsychotic Haldol)
  • NIH employees who are subordinates, relatives, or co-workers of the investigators, or NCCIH DIR employees.

EXCLUSION CRITERIA FOR INDIVIDUAL STUDY SESSION:

  • Shows signs of alcohol withdrawal syndrome, or has behavioral signs of intoxication: will be excluded immediately and not have the possibility to reschedule their session.
  • Used topical pain-relieving creams in the testing area (e.g. methylsalicylate, capsaicin) within 24 hours of testing or used non-steroidal anti-inflammatory drugs (NSAIDS, e.g. aspirin, ibuprofen), acetaminophen, or naproxen within 3 days of testing.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03937778
Other Study ID Numbers  ICMJE 190089
19-AT-0089
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Center for Complementary and Integrative Health (NCCIH) )
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexander T Chesler, Ph.D. National Center for Complementary and Integrative Health (NCCIH)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 11, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP