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

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).

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute; Motor Activity
• Intervention / Treatment: Procedure: pain delivery - learning only; Procedure: pain delivery - learning and retention

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Fath; Phone Number: (302) 283-9936; Email: fath@udel.edu

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • University of Delaware
      • Contact: Ashley Fath, MS; Phone Number: 302-283-9936; Email: fath@udel.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain Stimulus - Learning Only; Capsaicin combined with heat applied to intact skin	Procedure: pain delivery - learning only; 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.
Experimental: Pain Stimulus - Learning and Retention; Capsaicin combined with heat applied to intact skin	Procedure: pain delivery - learning and retention; 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.
No Intervention: No Stimulus; Nothing applied to skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	24 hours post learning (day 2)
Motor Learning Magnitude	degree to which the new locomotor pattern has been acquired (in step length percent change)	immediately after learning (day 1)

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Susanne M Morton, PhD, University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 20, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: pain; gait; acute pain; young adults; walking; motor learning; locomotion; generalization; motor consolidation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: 1786370-1.3; R01AG071585 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No