Pain and Motor Learning in Older Adults

• Sponsor: University of Delaware (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05471557
• Collaborator: (none)
• Enrollment: 102
• Arms: 3
• Anticipated Duration (Months): 30.1

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Aging; Pain, Acute; Cognitive Decline; Motor Activity	Procedure: pain delivery; Procedure: distractor delivery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: Application of pain or attentional control or no stimulus cannot be masked from participants, nor from outcomes assessors.
• Primary Purpose: Basic Science
• Official Title: Pain and Motor Learning in Older Adults
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pain Stimulus Capsaicin combined with heat applied to intact skin	Procedure: pain delivery; 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	Procedure: distractor delivery; Distractor stimulus delivered that is short-term and attention-demanding but not painful.
No Intervention: No Stimulus Nothing applied to skin

Outcome Measures

Primary Outcome Measures

1. Motor Retention Magnitude [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)

2. Motor Learning Magnitude [immediately after learning (day 1)]

   degree to which the new locomotor pattern has been acquired (in step length % change)

3. Digit Span Backward Test [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

4. Digit Span Forward Test [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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; HADS= Hospital Anxiety and Depression Scale.

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 HADS, anxiety subscale ≥ 11

6. Score on the HADS, depression subscale ≥ 11

7. Any current (within last 3 month) or chronic medical conditions, including any musculoskeletal, cardiovascular, endocrine, pulmonary, metabolic, psychiatric or neurological diagnosis (YA group only) 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Delaware

Investigators

• Principal Investigator: Susanne M Morton, PhD, University of Delaware

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Susanne M Morton, Associate Professor, University of Delaware
• ClinicalTrials.gov Identifier: NCT05471557
• Other Study ID Numbers: 1786370
• First Posted: Jul 25, 2022
• Last Update Posted: Jul 25, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Susanne M Morton, Associate Professor, University of Delaware: Acute pain; Adults; Cognition; Elderly; Learning; Memory; Pain; Cognitive ability; Motor learning; Young adults; Older Adults; Gait; Locomotion; Walking; Motor Consolidation
• Additional relevant MeSH terms: Acute Pain; Cognitive Dysfunction

Study Results

No Results Posted as of Jul 25, 2022