Effects of Acute Pain vs Context Change on Motor Learning Retention in Young Adults

Pain, Acute Clinical Trial

Official title:

Effects of Acute Pain vs Context Change on Motor Learning Retention in Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626582
• Other study ID #: 1786370-1.3
• Secondary ID: R01AG071585
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Est. completion date: May 31, 2024

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. When examining potential effects on retention of motor learning, it is important to dissociate any effects of pain from effects of a context change. The purpose of this research is to determine whether any altered retention of motor learning associated with acute pain is a true affect of pain or an affect of context (or both).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 31, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Abbreviations: 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 years old
• Self-identifying as generally medically healthy
• Able to read, write and speak English
• Able to provide informed consent
• 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
• 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
• 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
• 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
• 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

Related Conditions & MeSH terms

• Acute Pain
• Motor Activity
• Pain, Acute

Intervention

Procedure:
• pain delivery - learning only
Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful. Applied to skin just during the Day 1 learning period.
• pain delivery - learning and retention
Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful. Applied to skin during the Day 1 learning period and again during the Day 2 retention period.

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

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 percent 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 percent change)	immediately after learning (day 1)