- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05471557
Effects of Acute Pain on Motor Learning in Young vs Older Adults
April 2, 2024 updated by: Susanne M Morton, University of Delaware
To date, the effects of pain on motor learning have not been thoroughly investigated, particularly in older adults.
Broadly, the purpose of this research is to investigate the impact of acute pain on locomotor learning and its retention in older adults.
The investigators hypothesize that acute pain impairs retention of locomotor learning in young and older adults and that in older adults, these deficits are worsened and are related to the degree of normal age-related cognitive decline.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
102
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ashley Fath
- Phone Number: 302-283-9936
- Email: fath@udel.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Abbreviations: YA= young adult; OA= older adult; HR= heart rate, bpm= beats per minute; BP= blood pressure; ADD= attention deficit disorder; ADHD= attention deficit hyperactivity disorder; MoCA= Montreal Cognitive Assessment; GAD-7= Generalized Anxiety Disorder 7 Scale; PHQ-2, PHQ-9= Patient Health Questionnaire-2 and -9.
Inclusion Criteria:
- 18-35 (YA group only) or 55-85 (OA group only) years old
- Sex-matched to a participant in the OA group (YA group only)
- 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 or non-painful electrical stimulation, if selected
Exclusion Criteria:
- Resting HR < 50 or > 100 bpm
- Resting BP < 90/60 or > 140/95 mmHg (YA group only) or > 165/95 (OA group only)
- Any history or current mental health condition, learning/developmental disability or cognitive impairment, including ADD/ADHD, severe anxiety, severe depression, autism spectrum disorder, insomnia, mild cognitive impairment, etc.
- Score on the MoCA <23
- Score on the GAD-7 ≥ 10
- Score on the PHQ-2 ≥ 2 and score on the PHQ-9 ≥ 10
- Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, endocrine, pulmonary, metabolic, psychiatric or neurological diagnosis that (for OA group only) 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, or congestive heart failure, chronic obstructive pulmonary disorder, peripheral vascular disease)
- Any implanted electronic medical devices (i.e., cardiac pacemakers, cardiac defibrillators, spinal cord neurostimulators)
- Any impaired sensation or weakness in either lower extremity or in the area targeted for the stimulus
- 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
- Taking 4 or more medications (YA group only)
- 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 permitted, etc.)
- Any current or chronic pain condition during the last year, located anywhere in the body with a (OA group only) pain intensity of > 2/10
- Allergy to capsaicin or hot peppers
- Any skin lesion, breakage or irritation in the area targeted for the painful stimulus
- Skin sensitivity to soaps/creams/perfumes or to heat
- Poor circulation in the area targeted for the painful stimulus
- Prior participation in a locomotor learning study in this lab within the last 2 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No Stimulus
Nothing applied to skin
|
|
Experimental: Pain Stimulus
Capsaicin combined with heat applied to intact skin
|
Experimental pain paradigm delivered that is short-term and painful but not harmful.
|
Active Comparator: Distractor Somatosensory Stimulus
Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin
|
Distractor stimulus delivered that is short-term and attention-demanding but not painful.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor Retention Magnitude
Time Frame: 24 hours post learning (day 2)
|
degree to which the learned locomotor pattern has been remembered (in step length % change, normalized to the amount learned from day 1)
|
24 hours post learning (day 2)
|
Motor Learning Magnitude
Time Frame: immediately after learning (day 1)
|
degree to which the new locomotor pattern has been acquired (in step length % change)
|
immediately after learning (day 1)
|
Digit Span Backward Test
Time Frame: the change between baseline and during application of intervention
|
number of digits (numbers) that can be repeated back in the reverse order from which they were presented
|
the change between baseline and during application of intervention
|
Digit Span Forward Test
Time Frame: the change between baseline and during application of intervention
|
number of digits (numbers) that can be repeated back in the same order as they were presented
|
the change between baseline and during application of intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susanne M Morton, PhD, University of Delaware
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/
- Patel KV, Guralnik JM, Dansie EJ, Turk DC. Prevalence and impact of pain among older adults in the United States: findings from the 2011 National Health and Aging Trends Study. Pain. 2013 Dec;154(12):2649-2657. doi: 10.1016/j.pain.2013.07.029.
- Whitlock EL, Diaz-Ramirez LG, Glymour MM, Boscardin WJ, Covinsky KE, Smith AK. Association Between Persistent Pain and Memory Decline and Dementia in a Longitudinal Cohort of Elders. JAMA Intern Med. 2017 Aug 1;177(8):1146-1153. doi: 10.1001/jamainternmed.2017.1622.
- Higgins DM, Martin AM, Baker DG, Vasterling JJ, Risbrough V. The Relationship Between Chronic Pain and Neurocognitive Function: A Systematic Review. Clin J Pain. 2018 Mar;34(3):262-275. doi: 10.1097/AJP.0000000000000536.
- van der Leeuw G, Leveille SG, Dong Z, Shi L, Habtemariam D, Milberg W, Hausdorff JM, Grande L, Gagnon P, McLean RR, Bean JF. Chronic Pain and Attention in Older Community-Dwelling Adults. J Am Geriatr Soc. 2018 Jul;66(7):1318-1324. doi: 10.1111/jgs.15413. Epub 2018 Jun 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
March 15, 2025
Study Completion (Estimated)
March 30, 2025
Study Registration Dates
First Submitted
July 17, 2022
First Submitted That Met QC Criteria
July 20, 2022
First Posted (Actual)
July 25, 2022
Study Record Updates
Last Update Posted (Actual)
April 3, 2024
Last Update Submitted That Met QC Criteria
April 2, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1786370-1.1
- R01AG071585 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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