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Completed

NCT Number: NCT05625776

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.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pain delivery with capsaicin and heat

Procedure

Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful

distractor delivery with sensory TENS

Procedure

Distractor stimulus delivered (sensory TENS electrical stimulation) that is short-term and attention-demanding but not painful

Primary outcomes

  1. Digit Span Forward & Backward Test

    Time frame: the change between baseline and delivery (during application of intervention)

    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

  2. Trail Making Test A & B

    Time frame: the change between baseline and delivery (during application of intervention)

    time required to draw a line connecting a series of numbers (TM-A) or a series of alternating letters and numbers (TM-B)

Secondary outcomes

  1. Conner's Continuous Performance Test (CPT) 3

    Time frame: the change between baseline and delivery (during application of intervention)

    response time for letters vs. 'x' stimuli; number of correct inhibited responses

  2. Hopkins Verbal Learning Test- Revised

    Time frame: the change between baseline and delivery (during application of intervention)

    verbal memory for 3 semantic categories of 4 nouns each; immediate and delayed recall

  3. Brief Visuospatial Memory Test- Revised

    Time frame: the change between baseline and delivery (during application of intervention)

    visual memory for 6 shapes and their location on a page; immediate and delayed recall and recognition

  4. Stroop Test

    Time frame: the change between baseline and delivery (during application of intervention)

    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

  5. Wisconsin Card Sorting Test

    Time frame: the change between baseline and delivery (during application of intervention)

    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

  6. Delis Kaplan Executive Functional System (D-KEFS) - Verbal Fluency Section

    Time frame: the change between baseline and delivery (during application of intervention)

    number of words stated that match a certain category or start with a certain letter in a given time period

  7. NIH Toolbox Picture Sequence

    Time frame: the change between baseline and delivery (during application of intervention)

    reproduce the correct sequence of pictures

  8. NIH Toolbox Flanker

    Time frame: the change between baseline and delivery (during application of intervention)

    response time and errors when asked to focus on a single visual stimulus amongst distractors

  9. NIH Toolbox List Sorting

    Time frame: the change between baseline and delivery (during application of intervention)

    recall and sequencing of different visually and orally presented stimuli

  10. NIH Toolbox Dimension Change Card Sort

    Time frame: the change between baseline and delivery (during application of intervention)

    errors selecting the correct dimension upon which to select a card, a cue for which is provided

  11. NIH Toolbox Pattern Comparison

    Time frame: the change between baseline and during application of intervention

    errors and time required to determine whether several sets of two pictures are the same or not

  12. Wechsler 4th ed - Spatial Addition

    Time frame: the change between baseline and delivery (during application of intervention)

    errors and time required to add or subtract the location of circles on a screen based on a given set of rules

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 23, 2022
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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