Effects of Acute Pain on Cognitive Performance in Young Adults

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Acute Pain on Cognitive Performance in Young Adults

Conditions
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Pain, Acute, Cognition

Intervention / Treatment
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* Procedure: pain delivery with capsaicin and heat
* Procedure: distractor delivery with sensory TENS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Stimulus<br>Capsaicin combined with heat applied to intact skin | Procedure: pain delivery with capsaicin and heat<br>* Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful<br>|
| Active Comparator: Distractor Somatosensory Stimulus<br>Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin | Procedure: distractor delivery with sensory TENS<br>* Distractor stimulus delivered (sensory TENS electrical stimulation) that is short-term and attention-demanding but not painful<br>|
| No Intervention: No Stimulus<br>Nothing applied to skin | |

What is the study measuring?
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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 |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pain, cognition, pain, cognitive ability, young adults