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Effects of Acute Pain vs Context Change on Motor Learning Retention in Young Adults

Primary Purpose

Pain, Acute, Motor Activity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pain delivery - learning only
pain delivery - learning and retention
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain, Acute focused on measuring acute pain, young adults, pain, motor learning, motor consolidation, gait, locomotion, walking, generalization

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Abbreviations: 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 years old Self-identifying as generally medically healthy Able to read, write and speak English Able to provide informed consent 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 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 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 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 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

Sites / Locations

  • University of DelawareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Pain Stimulus - Learning Only

Pain Stimulus - Learning and Retention

No Stimulus

Arm Description

Capsaicin combined with heat applied to intact skin

Capsaicin combined with heat 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 percent 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 percent change)

Secondary Outcome Measures

Full Information

First Posted
November 13, 2022
Last Updated
May 9, 2023
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT05626582
Brief Title
Effects of Acute Pain vs Context Change on Motor Learning Retention in Young Adults
Official Title
Effects of Acute Pain vs Context Change on Motor Learning Retention in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (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. When examining potential effects on retention of motor learning, it is important to dissociate any effects of pain from effects of a context change. The purpose of this research is to determine whether any altered retention of motor learning associated with acute pain is a true affect of pain or an affect of context (or both).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Motor Activity
Keywords
acute pain, young adults, pain, motor learning, motor consolidation, gait, locomotion, walking, generalization

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 no stimulus cannot be masked from participants, nor from outcomes assessors.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain Stimulus - Learning Only
Arm Type
Experimental
Arm Description
Capsaicin combined with heat applied to intact skin
Arm Title
Pain Stimulus - Learning and Retention
Arm Type
Experimental
Arm Description
Capsaicin combined with heat 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 - learning only
Intervention Description
Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful. Applied to skin just during the Day 1 learning period.
Intervention Type
Procedure
Intervention Name(s)
pain delivery - learning and retention
Intervention Description
Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful. Applied to skin during the Day 1 learning period and again during the Day 2 retention period.
Primary Outcome Measure Information:
Title
Motor Retention Magnitude
Description
degree to which the learned locomotor pattern has been remembered (in step length percent 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 percent change)
Time Frame
immediately after learning (day 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Abbreviations: 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 years old Self-identifying as generally medically healthy Able to read, write and speak English Able to provide informed consent 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 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 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 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 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
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Fath, MS
Phone
302-283-9936
Email
fath@udel.edu

12. IPD Sharing Statement

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Effects of Acute Pain vs Context Change on Motor Learning Retention in Young Adults

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