Clinical trial NCT05625776: Effects of Acute Pain on Cognitive Performance in Young Adults
Official title: Effects of Acute Pain on Cognitive Performance in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Cognition
Keywords: acute pain
cognition
pain
cognitive ability
young adults
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-11-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Digit Span Forward & Backward Test
timeFrame: the change between baseline and delivery (during application of intervention)
measure: Trail Making Test A & B
timeFrame: the change between baseline and delivery (during application of intervention)
Secondary outcomes:
measure: Conner's Continuous Performance Test (CPT) 3
timeFrame: the change between baseline and delivery (during application of intervention)
measure: Hopkins Verbal Learning Test- Revised
timeFrame: the change between baseline and delivery (during application of intervention)
measure: Brief Visuospatial Memory Test- Revised
timeFrame: the change between baseline and delivery (during application of intervention)
measure: Stroop Test
timeFrame: the change between baseline and delivery (during application of intervention)
measure: Wisconsin Card Sorting Test
timeFrame: the change between baseline and delivery (during application of intervention)
measure: Delis Kaplan Executive Functional System (D-KEFS) - Verbal Fluency Section
timeFrame: the change between baseline and delivery (during application of intervention)
measure: NIH Toolbox Picture Sequence
timeFrame: the change between baseline and delivery (during application of intervention)
measure: NIH Toolbox Flanker
timeFrame: the change between baseline and delivery (during application of intervention)
measure: NIH Toolbox List Sorting
timeFrame: the change between baseline and delivery (during application of intervention)
measure: NIH Toolbox Dimension Change Card Sort
timeFrame: the change between baseline and delivery (during application of intervention)
measure: NIH Toolbox Pattern Comparison
timeFrame: the change between baseline and during application of intervention
measure: Wechsler 4th ed - Spatial Addition
timeFrame: the change between baseline and delivery (during application of intervention)
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
affiliation: University of Delaware
name: Susanne M Morton, PhD
role: PRINCIPAL_INVESTIGATOR
References: