NCT05471557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
2.1 years until next milestone

Study Start

First participant enrolled

August 20, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2025

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

July 17, 2022

Last Update Submit

December 3, 2025

Conditions

Keywords

Acute painAdultsCognitionElderlyLearningMemoryPainCognitive abilityMotor learningYoung adultsOlder AdultsGaitLocomotionWalkingMotor Consolidation

Outcome Measures

Primary Outcomes (4)

  • 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)

    24 hours post learning (day 2)

  • Motor Learning Magnitude

    degree to which the new locomotor pattern has been acquired (in step length % change)

    immediately after learning (day 1)

  • Digit Span Backward Test

    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

    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

Study Arms (2)

Pain Stimulus

EXPERIMENTAL

Capsaicin combined with heat applied to intact skin

Procedure: pain delivery

No Stimulus

NO INTERVENTION

Nothing applied to skin

Interventions

pain deliveryPROCEDURE

Experimental pain paradigm delivered that is short-term and painful but not harmful.

Pain Stimulus

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • 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 severe untreated ADD/ADHD, severe untreated anxiety, severe untreated 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 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

Related Publications (5)

  • 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.

    PMID: 24287107BACKGROUND
  • 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.

    PMID: 28586818BACKGROUND
  • 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.

    PMID: 28719507BACKGROUND
  • 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/

    PMID: 22553896BACKGROUND
  • 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.

    PMID: 29876923BACKGROUND

MeSH Terms

Conditions

Acute PainCognitive DysfunctionMotor ActivityPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Susanne M Morton, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Application of pain or no stimulus cannot be masked from participants, nor from outcomes assessors.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 17, 2022

First Posted

July 25, 2022

Study Start

August 20, 2024

Primary Completion

June 5, 2025

Study Completion

June 5, 2025

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations