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Recruiting NCT07054840

Pain and Split-belt Motor Learning in Older Adults

No phase Interventional Aging Older Adults Pain Motor Learning

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Capsaicin 0.1% cream combined with a heat pack and applied to the lower leg.
Who it may be relevant to
Registry conditions: Aging, Older Adults, Pain, Motor Learning. Basic parameters: 55 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral 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 measures

  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Health Sciences Complex — Newark

Identifiers

NCT: NCT07054840 · 2334309

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗