Effects of Acute Pain on Cognitive Performance in Young Adults

Sponsor
University of Delaware (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05625776
Collaborator
(none)
50
3
5.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: pain delivery with capsaicin and heat
  • Procedure: distractor delivery with sensory TENS
  • Device: transcutaneous electrical nerve stimulation (TENS)
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 attentional control or no stimulus cannot be masked from participants, nor from outcomes assessors.
Primary Purpose:
Basic Science
Official Title:
Effects of Acute Pain on Cognitive Performance in Young Adults
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 15, 2023
Anticipated Study Completion Date :
Jul 15, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Device: transcutaneous electrical nerve stimulation (TENS)
transcutaneous electrical nerve stimulation (TENS)

No Intervention: No Stimulus

Nothing applied to skin

Outcome Measures

Primary Outcome Measures

  1. Digit Span Forward & Backward Test [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 [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 Outcome Measures

  1. Conner's CPT 3 [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 [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 [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 [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 [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 [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 [the change between baseline and delivery (during application of intervention)]

    reproduce the correct sequence of pictures

  8. NIH Toolbox Flanker [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 [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 [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 [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 [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

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:
  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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Delaware

Investigators

  • Principal Investigator: Susanne M Morton, PhD, University of Delaware

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Susanne M Morton, Associate Professor, University of Delaware
ClinicalTrials.gov Identifier:
NCT05625776
Other Study ID Numbers:
  • 1786370-1.2
First Posted:
Nov 23, 2022
Last Update Posted:
Dec 14, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Susanne M Morton, Associate Professor, University of Delaware
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 14, 2022