Effects of Acute Pain on Motor Learning in Young vs Older Adults

Aging Clinical Trial

Official title:

Effects of Acute Pain on Motor Learning in Young vs Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05471557
• Other study ID #: 1786370-1.1
• Secondary ID: R01AG071585
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: April 2024
• Source: University of Delaware
• Contact: Ashley Fath
• Phone: 302-283-9936
• Email: fath[@]udel.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 102
• Est. completion date: March 30, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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:

1. 18-35 (YA group only) or 55-85 (OA group only) years old

2. Sex-matched to a participant in the OA group (YA group only)

3. Self-identifying as generally medically healthy

4. Able to read, write and speak English

5. Able to provide informed consent and attend all testing sessions

6. Willing to undergo the experimental pain or non-painful electrical stimulation, if selected

Exclusion Criteria:

1. Resting HR < 50 or > 100 bpm

2. Resting BP < 90/60 or > 140/95 mmHg (YA group only) or > 165/95 (OA group only)

3. 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.

4. Score on the MoCA <23

5. Score on the GAD-7 = 10

6. Score on the PHQ-2 = 2 and score on the PHQ-9 = 10

7. 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)

8. Any implanted electronic medical devices (i.e., cardiac pacemakers, cardiac defibrillators, spinal cord neurostimulators)

9. Any impaired sensation or weakness in either lower extremity or in the area targeted for the stimulus

10. 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

11. Any history of acute or chronic problems with balance, any dizziness, or > 1 fall in the last 12 months

12. Taking 4 or more medications (YA group only)

13. 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.)

14. 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

15. Allergy to capsaicin or hot peppers

16. Any skin lesion, breakage or irritation in the area targeted for the painful stimulus

17. Skin sensitivity to soaps/creams/perfumes or to heat

18. Poor circulation in the area targeted for the painful stimulus

19. Prior participation in a locomotor learning study in this lab within the last 2 years.

Related Conditions & MeSH terms

• Acute Pain
• Aging
• Cognitive Decline
• Cognitive Dysfunction
• Motor Activity
• Pain, Acute

Intervention

Procedure:
• pain delivery
Experimental pain paradigm delivered that is short-term and painful but not harmful.
• distractor delivery
Distractor stimulus delivered that is short-term and attention-demanding but not painful.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	National Institute on Aging (NIA)

References & Publications (5)

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. — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor Retention Magnitude	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)
Primary	Motor Learning Magnitude	degree to which the new locomotor pattern has been acquired (in step length % change)	immediately after learning (day 1)
Primary	Digit Span Backward Test	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
Primary	Digit Span Forward Test	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