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Effects of Acute Pain on Cognitive Performance in Young Adults

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University of Delaware

Status

Completed

Conditions

Pain, Acute
Cognition

Treatments

Procedure: distractor delivery with sensory TENS
Procedure: pain delivery with capsaicin and heat

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05625776
R01AG071585 (U.S. NIH Grant/Contract)
1786370-1.2

Details and patient eligibility

About

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.

Enrollment

23 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

23 participants in 3 patient groups

Pain Stimulus
Experimental group
Description:
Capsaicin combined with heat applied to intact skin
Treatment:
Procedure: pain delivery with capsaicin and heat
Distractor Somatosensory Stimulus
Active Comparator group
Description:
Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin
Treatment:
Procedure: distractor delivery with sensory TENS
No Stimulus
No Intervention group
Description:
Nothing applied to skin

Trial contacts and locations

1

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Central trial contact

Ashley Fath

Data sourced from clinicaltrials.gov

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