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NCT Number: NCT07054840

Pain and Split-belt Motor Learning in Older Adults

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.

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Key information

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences Complex

Newark, Delaware, 19713, United States

Location status: Recruiting

Location contact

Ashley Fath

CONTACT

[email protected]

302-283-9936

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Poor circulation in the area targeted for the painful stimulus
  • Prior participation in a split-belt locomotor learning study in the Neuromotor Behavior Lab in the past 2 years

Treatment and study plan

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.

Primary outcomes

  1. Learning magnitude

    Time frame: End of day 1

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

  2. Retention magnitude

    Time frame: Beginning of day 2.

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

  3. Forgetting index

    Time frame: End of day 1 and beginning of day 2.

    Difference between retention magnitude and learning magnitude.

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley Fath

CONTACT

[email protected]

302-283-9936

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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