Effects of Acute Pain on Cognitive Performance in Young Adults

Pain, Acute Clinical Trial

Official title:

Effects of Acute Pain on Cognitive Performance in Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05625776
• Other study ID #: 1786370-1.2
• Secondary ID: R01AG071585
• Status: Completed
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: November 16, 2023

Study information

• Verified date: December 2023
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 16, 2023
• Est. primary completion date: November 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Cognition
• Pain, Acute

Intervention

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

Locations

Country	Name	City	State
United States	University of Delaware	Newark	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
University of Delaware	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	NIH Toolbox Picture Sequence	reproduce the correct sequence of pictures	the change between baseline and delivery (during application of intervention)
Secondary	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)
Secondary	NIH Toolbox List Sorting	recall and sequencing of different visually and orally presented stimuli	the change between baseline and delivery (during application of intervention)
Secondary	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)
Secondary	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
Secondary	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)