Pain and Split-belt Motor Learning in Older Adults

NCT07054840 | Recruiting

• 1 other identifier: 2334309
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to investigate the impact of acute pain, induced using an experimental pain paradigm of capsaicin paired with heat, on implicit locomotor learning and its retention in older adults.

Conditions

Aging; Older Adults; Pain; Motor Learning

Outcome Measures

Primary Outcomes (3)

• Learning magnitude

  Step length asymmetry averaged over the last 25 strides of the practice period on day 1.

  End of day 1

• Retention magnitude

  Step length asymmetry averaged over the first 4 strides of the re-adaptation period on day 2.

  Beginning of day 2.

• Forgetting index

  Difference between retention magnitude and learning magnitude.

  End of day 1 and beginning of day 2.

Study Arms (2)

No Pain

NO INTERVENTION

Will receive no intervention.

Pain

EXPERIMENTAL

Will receive capsaicin and heat combined to induce acute pain.

Behavioral: Capsaicin 0.1% cream combined with a heat pack and applied to the lower leg

Interventions

Capsaicin 0.1% cream combined with a heat pack and applied to the lower leg BEHAVIORAL

Capsaicin is applied to the skin of one of the lower legs, then covered with a heat pack that is secured to the leg with self-adhesive wrap.

Pain

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55-90 years old
• 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 paradigm, if selected

You may not qualify if:

• Resting heart rate \< 50 or \> 100 bpm
• Resting blood pressure \< 90/60 or \> 165/95
• 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. (Mild to moderate treated ADD/ADHD, anxiety, and/or depression are allowed.)
• Score on the Montreal Cognitive Assessment (MoCA) \<23
• Score on the Generalized Anxiety Disorder-7 Scale ≥ 10
• Score on the Patient Health Questionnaire-2 ≥ 2 and score on the Patient Health Questionnaire-9 ≥ 10
• Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, pulmonary, metabolic, psychiatric or neurological diagnosis that 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, congestive heart failure, chronic obstructive pulmonary disorder, or peripheral vascular disease)
• Any impaired sensation or weakness in either lower extremity
• 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
• 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 is allowed)
• Any current or chronic pain condition during the last year, located anywhere in the body with an intensity of \> 2/10
• Allergy to capsaicin or hot peppers
• Any skin lesion, breakage or irritation in the area targeted for the painful stimulus
• Significant skin sensitivity to soaps/creams/perfumes or to heat

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

Health Sciences Complex

Newark, Delaware, 19713, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Susanne Morton

  University of Delaware

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley Fath

CONTACT

302-283-9936; RNP-Lab@udel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)