Effects of Acute Pain on Cognitive Performance in Young Adults

The effects of pain on cognitive performance have not been thoroughly investigated. Broadly, the purpose of this research is to investigate the effects of acute pain on performance of a variety of cognitive performance measures. The investigators hypothesize that acute pain impairs cognitive performance, particularly cognitive measures of working memory, attention, and processing speed.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Cognition
• Intervention / Treatment: Procedure: pain delivery with capsaicin and heat; Procedure: distractor delivery with sensory TENS

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • University of Delaware

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

1. 18-35 years old
2. Self-identifying as generally medically healthy
3. Able to read, write and speak English
4. Able to provide informed consent
5. 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
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
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
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
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Stimulus; Nothing applied to skin
Experimental: Pain Stimulus; Capsaicin combined with heat applied to intact skin	Procedure: pain delivery with capsaicin and heat; Experimental pain paradigm delivered (capsaicin cream combined with heat) 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 with sensory TENS; Distractor stimulus delivered (sensory TENS electrical stimulation) that is short-term and attention-demanding but not painful

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digit Span Forward & Backward Test	number of digits (numbers) that can be repeated back in the same (DS forward) or the reverse (DS backward( order from which they were presented	the change between baseline and delivery (during application of intervention)
Trail Making Test A & B	time required to draw a line connecting a series of numbers (TM-A) or a series of alternating letters and numbers (TM-B)	the change between baseline and delivery (during application of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hopkins Verbal Learning Test- Revised	verbal memory for 3 semantic categories of 4 nouns each; immediate and delayed recall	the change between baseline and delivery (during application of intervention)
Brief Visuospatial Memory Test- Revised	visual memory for 6 shapes and their location on a page; immediate and delayed recall and recognition	the change between baseline and delivery (during application of intervention)
Stroop Test	response time and number of errors when stating the name of words printed in a congruent, neutral or incongruent color compared to the meaning of the words	the change between baseline and delivery (during application of intervention)
Wisconsin Card Sorting Test	number of trials taken to deduce the new rule when the rules of a card game are changed without warning and without knowing what any of the rules are	the change between baseline and delivery (during application of intervention)
Delis Kaplan Executive Functional System (D-KEFS) - Verbal Fluency Section	number of words stated that match a certain category or start with a certain letter in a given time period	the change between baseline and delivery (during application of intervention)
NIH Toolbox Picture Sequence	reproduce the correct sequence of pictures	the change between baseline and delivery (during application of intervention)
NIH Toolbox Flanker	response time and errors when asked to focus on a single visual stimulus amongst distractors	the change between baseline and delivery (during application of intervention)
NIH Toolbox List Sorting	recall and sequencing of different visually and orally presented stimuli	the change between baseline and delivery (during application of intervention)
NIH Toolbox Dimension Change Card Sort	errors selecting the correct dimension upon which to select a card, a cue for which is provided	the change between baseline and delivery (during application of intervention)
NIH Toolbox Pattern Comparison	errors and time required to determine whether several sets of two pictures are the same or not	the change between baseline and during application of intervention
Wechsler 4th ed - Spatial Addition	errors and time required to add or subtract the location of circles on a screen based on a given set of rules	the change between baseline and delivery (during application of intervention)
Conner's Continuous Performance Test (CPT) 3	response time for letters vs. 'x' stimuli; number of correct inhibited responses	the change between baseline and delivery (during application of intervention)

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Susanne M Morton, PhD, University of Delaware

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): November 16, 2023
• Study Completion (Actual): November 16, 2023

Study Registration Dates

• First Submitted: November 13, 2022
• First Submitted That Met QC Criteria: November 22, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: pain; cognition; acute pain; young adults; cognitive ability
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: 1786370-1.2; R01AG071585 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No