AgingNCT07054840
Pain and Split-belt Motor Learning in Older Adults
A study testing Capsaicin 0.1% cream combined with a heat pack and applied to the lower leg in people with Aging and Older Adults, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Aging, Older Adults, Pain
- What is being tested?
- Capsaicin 0.1% cream combined with a heat pack and applied to the lower leg
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Health Sciences Complex
Newark, Delaware, 19713
Ashley Fath, 302-283-9936, RNP-Lab@udel.edu
About this study
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
- Being tested
- Capsaicin 0.1% cream combined with a heat pack and applied to the lower leg
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin 0.1% cream combined with a heat pack and applied to the lower legBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No Pain | No intervention | Will receive no intervention. |
| Pain | Experimental | Will receive capsaicin and heat combined to induce acute pain. Receives: Behavioral: Capsaicin 0.1% cream combined with a heat pack and applied to the lower leg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning magnitude
Step length asymmetry averaged over the last 25 strides of the practice period on day 1.
Measured: End of day 1
Retention magnitude
Step length asymmetry averaged over the first 4 strides of the re-adaptation period on day 2.
Measured: Beginning of day 2.
Forgetting index
Difference between retention magnitude and learning magnitude.
Measured: End of day 1 and beginning of day 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start26 Aug 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Morton, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054840
- Sponsor's protocol ID
- 2334309
- Status last verified
- Dec 2025
- First submitted
- 27 Jun 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Split-belt Motor Learning in Older Adults
- ClinicalTrials.gov ID
- NCT07054840
- Acronym / sponsor ID
- 2334309
- Conditions
- Aging, Older Adults, Pain, Motor Learning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 26 Aug 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Pain | No intervention | –Will receive no intervention. |
| Pain | Experimental | Behavioral: Capsaicin 0.1% cream combined with a heat pack and applied to the lower legWill receive capsaicin and heat combined to induce acute pain. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin 0.1% cream combined with a heat pack and applied to the lower legCapsaicin 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. | Behavioural | Pain |
Primary outcome
Learning magnitude
Time frame: End of day 1
Step length asymmetry averaged over the last 25 strides of the practice period on day 1.
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.
Forgetting index
Time frame: End of day 1 and beginning of day 2.
Difference between retention magnitude and learning magnitude.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanne Morton principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicin 0.1% cream combined with a heat pack and applied to the lower leg in people with Aging and Older Adults, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Fath (302-283-9936, RNP-Lab@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Learning magnitude (time frame: End of day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.