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Effects of Acute Pain on Motor Learning in Young vs Older Adults

Primary Purpose

Aging, Pain, Acute, Cognitive Decline

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pain delivery
distractor delivery
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Aging focused on measuring Acute pain, Adults, Cognition, Elderly, Learning, Memory, Pain, Cognitive ability, Motor learning, Young adults, Older Adults, Gait, Locomotion, Walking, Motor Consolidation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Abbreviations: YA= young adult; OA= older adult; HR= heart rate, bpm= beats per minute; BP= blood pressure; ADD= attention deficit disorder; ADHD= attention deficit hyperactivity disorder; MoCA= Montreal Cognitive Assessment; GAD-7= Generalized Anxiety Disorder 7 Scale; PHQ-2, PHQ-9= Patient Health Questionnaire-2 and -9.

Inclusion Criteria:

  1. 18-35 (YA group only) or 55-85 (OA group only) years old
  2. Sex-matched to a participant in the OA group (YA group only)
  3. Self-identifying as generally medically healthy
  4. Able to read, write and speak English
  5. Able to provide informed consent and attend all testing sessions
  6. Willing to undergo the experimental pain or non-painful electrical stimulation, if selected

Exclusion Criteria:

  1. Resting HR < 50 or > 100 bpm
  2. Resting BP < 90/60 or > 140/95 mmHg (YA group only) or > 165/95 (OA group only)
  3. Any history or current mental health condition, learning/developmental disability or cognitive impairment, including ADD/ADHD, severe anxiety, severe depression, autism spectrum disorder, insomnia, mild cognitive impairment, etc.
  4. Score on the MoCA <23
  5. Score on the GAD-7 ≥ 10
  6. Score on the PHQ-2 ≥ 2 and score on the PHQ-9 ≥ 10
  7. Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, endocrine, pulmonary, metabolic, psychiatric or neurological diagnosis that (for OA group only) affects activities of daily living or would confound testing or place the subject at risk by participating, such as a significant cardiovascular condition or event (e.g., heart attack < 3 months ago, uncontrolled atrial fibrillation, uncontrolled angina, or congestive heart failure, chronic obstructive pulmonary disorder, peripheral vascular disease)
  8. Any implanted electronic medical devices (i.e., cardiac pacemakers, cardiac defibrillators, spinal cord neurostimulators)
  9. Any impaired sensation or weakness in either lower extremity or in the area targeted for the stimulus
  10. History of serious concussion or head injury, defined as a loss of consciousness for > 5 minutes and/or requiring medical treatment, or > 2 concussions over the lifespan
  11. Any history of acute or chronic problems with balance, any dizziness, or > 1 fall in the last 12 months
  12. Taking 4 or more medications (YA group only)
  13. Currently or regularly using any analgesic medications, over-the-counter remedies, or any other treatment for the purposes of pain relief (i.e., baby aspirin for heart health permitted, etc.)
  14. Any current or chronic pain condition during the last year, located anywhere in the body with a (OA group only) pain intensity of > 2/10
  15. Allergy to capsaicin or hot peppers
  16. Any skin lesion, breakage or irritation in the area targeted for the painful stimulus
  17. Skin sensitivity to soaps/creams/perfumes or to heat
  18. Poor circulation in the area targeted for the painful stimulus
  19. Prior participation in a locomotor learning study in this lab within the last 2 years.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Pain Stimulus

    Distractor Somatosensory Stimulus

    No Stimulus

    Arm Description

    Capsaicin combined with heat applied to intact skin

    Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin

    Nothing applied to skin

    Outcomes

    Primary Outcome Measures

    Motor Retention Magnitude
    degree to which the learned locomotor pattern has been remembered (in step length % change, normalized to the amount learned from day 1)
    Motor Learning Magnitude
    degree to which the new locomotor pattern has been acquired (in step length % change)
    Digit Span Backward Test
    number of digits (numbers) that can be repeated back in the reverse order from which they were presented
    Digit Span Forward Test
    number of digits (numbers) that can be repeated back in the same order as they were presented

    Secondary Outcome Measures

    Full Information

    First Posted
    July 17, 2022
    Last Updated
    May 9, 2023
    Sponsor
    University of Delaware
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05471557
    Brief Title
    Effects of Acute Pain on Motor Learning in Young vs Older Adults
    Official Title
    Effects of Acute Pain on Motor Learning in Young vs Older Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    August 15, 2024 (Anticipated)
    Study Completion Date
    August 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Delaware

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To date, the effects of pain on motor learning have not been thoroughly investigated, particularly in older adults. Broadly, the purpose of this research is to investigate the impact of acute pain on locomotor learning and its retention in older adults. The investigators hypothesize that acute pain impairs retention of locomotor learning in young and older adults and that in older adults, these deficits are worsened and are related to the degree of normal age-related cognitive decline.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aging, Pain, Acute, Cognitive Decline, Motor Activity
    Keywords
    Acute pain, Adults, Cognition, Elderly, Learning, Memory, Pain, Cognitive ability, Motor learning, Young adults, Older Adults, Gait, Locomotion, Walking, Motor Consolidation

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Masking Description
    Application of pain or attentional control or no stimulus cannot be masked from participants, nor from outcomes assessors.
    Allocation
    Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pain Stimulus
    Arm Type
    Experimental
    Arm Description
    Capsaicin combined with heat applied to intact skin
    Arm Title
    Distractor Somatosensory Stimulus
    Arm Type
    Active Comparator
    Arm Description
    Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin
    Arm Title
    No Stimulus
    Arm Type
    No Intervention
    Arm Description
    Nothing applied to skin
    Intervention Type
    Procedure
    Intervention Name(s)
    pain delivery
    Intervention Description
    Experimental pain paradigm delivered that is short-term and painful but not harmful.
    Intervention Type
    Procedure
    Intervention Name(s)
    distractor delivery
    Intervention Description
    Distractor stimulus delivered that is short-term and attention-demanding but not painful.
    Primary Outcome Measure Information:
    Title
    Motor Retention Magnitude
    Description
    degree to which the learned locomotor pattern has been remembered (in step length % change, normalized to the amount learned from day 1)
    Time Frame
    24 hours post learning (day 2)
    Title
    Motor Learning Magnitude
    Description
    degree to which the new locomotor pattern has been acquired (in step length % change)
    Time Frame
    immediately after learning (day 1)
    Title
    Digit Span Backward Test
    Description
    number of digits (numbers) that can be repeated back in the reverse order from which they were presented
    Time Frame
    the change between baseline and during application of intervention
    Title
    Digit Span Forward Test
    Description
    number of digits (numbers) that can be repeated back in the same order as they were presented
    Time Frame
    the change between baseline and during application of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Abbreviations: YA= young adult; OA= older adult; HR= heart rate, bpm= beats per minute; BP= blood pressure; ADD= attention deficit disorder; ADHD= attention deficit hyperactivity disorder; MoCA= Montreal Cognitive Assessment; GAD-7= Generalized Anxiety Disorder 7 Scale; PHQ-2, PHQ-9= Patient Health Questionnaire-2 and -9. Inclusion Criteria: 18-35 (YA group only) or 55-85 (OA group only) years old Sex-matched to a participant in the OA group (YA group only) Self-identifying as generally medically healthy Able to read, write and speak English Able to provide informed consent and attend all testing sessions Willing to undergo the experimental pain or non-painful electrical stimulation, if selected Exclusion Criteria: Resting HR < 50 or > 100 bpm Resting BP < 90/60 or > 140/95 mmHg (YA group only) or > 165/95 (OA group only) Any history or current mental health condition, learning/developmental disability or cognitive impairment, including ADD/ADHD, severe anxiety, severe depression, autism spectrum disorder, insomnia, mild cognitive impairment, etc. Score on the MoCA <23 Score on the GAD-7 ≥ 10 Score on the PHQ-2 ≥ 2 and score on the PHQ-9 ≥ 10 Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, endocrine, pulmonary, metabolic, psychiatric or neurological diagnosis that (for OA group only) affects activities of daily living or would confound testing or place the subject at risk by participating, such as a significant cardiovascular condition or event (e.g., heart attack < 3 months ago, uncontrolled atrial fibrillation, uncontrolled angina, or congestive heart failure, chronic obstructive pulmonary disorder, peripheral vascular disease) Any implanted electronic medical devices (i.e., cardiac pacemakers, cardiac defibrillators, spinal cord neurostimulators) Any impaired sensation or weakness in either lower extremity or in the area targeted for the stimulus History of serious concussion or head injury, defined as a loss of consciousness for > 5 minutes and/or requiring medical treatment, or > 2 concussions over the lifespan Any history of acute or chronic problems with balance, any dizziness, or > 1 fall in the last 12 months Taking 4 or more medications (YA group only) Currently or regularly using any analgesic medications, over-the-counter remedies, or any other treatment for the purposes of pain relief (i.e., baby aspirin for heart health permitted, etc.) Any current or chronic pain condition during the last year, located anywhere in the body with a (OA group only) pain intensity of > 2/10 Allergy to capsaicin or hot peppers Any skin lesion, breakage or irritation in the area targeted for the painful stimulus Skin sensitivity to soaps/creams/perfumes or to heat Poor circulation in the area targeted for the painful stimulus Prior participation in a locomotor learning study in this lab within the last 2 years.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashley Fath
    Phone
    302-283-9936
    Email
    fath@udel.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Susanne M Morton, PhD
    Organizational Affiliation
    University of Delaware
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24287107
    Citation
    Patel KV, Guralnik JM, Dansie EJ, Turk DC. Prevalence and impact of pain among older adults in the United States: findings from the 2011 National Health and Aging Trends Study. Pain. 2013 Dec;154(12):2649-2657. doi: 10.1016/j.pain.2013.07.029.
    Results Reference
    background
    PubMed Identifier
    28586818
    Citation
    Whitlock EL, Diaz-Ramirez LG, Glymour MM, Boscardin WJ, Covinsky KE, Smith AK. Association Between Persistent Pain and Memory Decline and Dementia in a Longitudinal Cohort of Elders. JAMA Intern Med. 2017 Aug 1;177(8):1146-1153. doi: 10.1001/jamainternmed.2017.1622.
    Results Reference
    background
    PubMed Identifier
    28719507
    Citation
    Higgins DM, Martin AM, Baker DG, Vasterling JJ, Risbrough V. The Relationship Between Chronic Pain and Neurocognitive Function: A Systematic Review. Clin J Pain. 2018 Mar;34(3):262-275. doi: 10.1097/AJP.0000000000000536.
    Results Reference
    background
    PubMed Identifier
    22553896
    Citation
    Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/
    Results Reference
    background
    PubMed Identifier
    29876923
    Citation
    van der Leeuw G, Leveille SG, Dong Z, Shi L, Habtemariam D, Milberg W, Hausdorff JM, Grande L, Gagnon P, McLean RR, Bean JF. Chronic Pain and Attention in Older Community-Dwelling Adults. J Am Geriatr Soc. 2018 Jul;66(7):1318-1324. doi: 10.1111/jgs.15413. Epub 2018 Jun 6.
    Results Reference
    background

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