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

April 2, 2024 updated by: Susanne M Morton, University of Delaware
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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ashley Fath
  • Phone Number: 302-283-9936
  • Email: fath@udel.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Stimulus
Nothing applied to skin
Experimental: Pain Stimulus
Capsaicin combined with heat applied to intact skin
Experimental pain paradigm delivered that is short-term and painful but not harmful.
Active Comparator: Distractor Somatosensory Stimulus
Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin
Distractor stimulus delivered that is short-term and attention-demanding but not painful.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Retention Magnitude
Time Frame: 24 hours post learning (day 2)
degree to which the learned locomotor pattern has been remembered (in step length % change, normalized to the amount learned from day 1)
24 hours post learning (day 2)
Motor Learning Magnitude
Time Frame: immediately after learning (day 1)
degree to which the new locomotor pattern has been acquired (in step length % change)
immediately after learning (day 1)
Digit Span Backward Test
Time Frame: the change between baseline and during application of intervention
number of digits (numbers) that can be repeated back in the reverse order from which they were presented
the change between baseline and during application of intervention
Digit Span Forward Test
Time Frame: the change between baseline and during application of intervention
number of digits (numbers) that can be repeated back in the same order as they were presented
the change between baseline and during application of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susanne M Morton, PhD, University of Delaware

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

July 17, 2022

First Submitted That Met QC Criteria

July 20, 2022

First Posted (Actual)

July 25, 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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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