NCT05626582

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 23, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

April 11, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

1.1 years

First QC Date

November 13, 2022

Last Update Submit

July 11, 2024

Conditions

Keywords

acute painyoung adultspainmotor learningmotor consolidationgaitlocomotionwalkinggeneralization

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Motor Learning Magnitude

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

    immediately after learning (day 1)

Study Arms (3)

Pain Stimulus - Learning Only

EXPERIMENTAL

Capsaicin combined with heat applied to intact skin

Procedure: pain delivery - learning only

Pain Stimulus - Learning and Retention

EXPERIMENTAL

Capsaicin combined with heat applied to intact skin

Procedure: pain delivery - learning and retention

No Stimulus

NO INTERVENTION

Nothing applied to skin

Interventions

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 Stimulus - Learning Only

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.

Pain Stimulus - Learning and Retention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Acute PainMotor ActivityPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Susanne M Morton, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Application of pain or no stimulus cannot be masked from participants, nor from outcomes assessors.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 13, 2022

First Posted

November 23, 2022

Study Start

April 11, 2023

Primary Completion

May 15, 2024

Study Completion

May 31, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations