Recruiting

Capsaicin

Sponsor:

University of Delaware

Code:

NCT07054840

Conditions

Aging

Older Adults

Pain

Motor Learning

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07054840

Start date

Aug 26, 2025

Status verified date

Dec, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

May 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: No Pain

Will receive no intervention.

experimental: Pain

Will receive capsaicin and heat combined to induce acute pain.

Interventions

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

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 outcome measure

  • Learning magnitude [ Time Frame: End of day 1 ]
  • Retention magnitude [ Time Frame: Beginning of day 2. ]
  • Forgetting index [ Time Frame: End of day 1 and beginning of day 2. ]

Central Contacts and Locations

Central contacts

Ashley Fath

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

Locations

Health Sciences Complex

Recruiting

Newark, Delaware, United States, 19713

Contacts

Ashley Fath

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

More Information

Sponsor

University of Delaware

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Delaware on 2025-12-04.