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

Sponsor

University of Delaware (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05626582

Collaborator

(none)

Enrollment

Arms

10.4

Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute Motor Activity	Procedure: pain delivery - learning only Procedure: pain delivery - learning and retention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

Application of pain or no stimulus cannot be masked from participants, nor from outcomes assessors.

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pain Stimulus - Learning Only Capsaicin combined with heat applied to intact skin	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.
Experimental: Pain Stimulus - Learning and Retention Capsaicin combined with heat applied to intact skin	Procedure: 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.
No Intervention: No Stimulus Nothing applied to skin

Arm

Intervention/Treatment

Experimental: Pain Stimulus - Learning Only

Capsaicin combined with heat applied to intact skin

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.

Experimental: Pain Stimulus - Learning and Retention

Capsaicin combined with heat applied to intact skin

Procedure: 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.

No Intervention: No Stimulus

Nothing applied to skin

Outcome Measures

Primary Outcome Measures

Motor Retention Magnitude [24 hours post learning (day 2)]
degree to which the learned locomotor pattern has been remembered (in step length percent change, normalized to the amount learned from day 1)
Motor Learning Magnitude [immediately after learning (day 1)]
degree to which the new locomotor pattern has been acquired (in step length percent change)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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