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Effects of Acute Pain on Cognitive Performance in Young Adults

Primary Purpose

Pain, Acute, Cognition

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pain delivery with capsaicin and heat
distractor delivery with sensory TENS
transcutaneous electrical nerve stimulation (TENS)
Sponsored by
University of Delaware
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pain, Acute focused on measuring acute pain, cognition, pain, cognitive ability, young adults

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of DelawareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Pain Stimulus

Distractor Somatosensory Stimulus

No Stimulus

Arm Description

Capsaicin combined with heat applied to intact skin

Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin

Nothing applied to skin

Outcomes

Primary Outcome Measures

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
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)

Secondary Outcome Measures

Conner's CPT 3
response time for letters vs. 'x' stimuli; number of correct inhibited responses
Hopkins Verbal Learning Test- Revised
verbal memory for 3 semantic categories of 4 nouns each; immediate and delayed recall
Brief Visuospatial Memory Test- Revised
visual memory for 6 shapes and their location on a page; immediate and delayed recall and recognition
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
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
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
NIH Toolbox Picture Sequence
reproduce the correct sequence of pictures
NIH Toolbox Flanker
response time and errors when asked to focus on a single visual stimulus amongst distractors
NIH Toolbox List Sorting
recall and sequencing of different visually and orally presented stimuli
NIH Toolbox Dimension Change Card Sort
errors selecting the correct dimension upon which to select a card, a cue for which is provided
NIH Toolbox Pattern Comparison
errors and time required to determine whether several sets of two pictures are the same or not
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

Full Information

First Posted
November 13, 2022
Last Updated
May 13, 2023
Sponsor
University of Delaware
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1. Study Identification

Unique Protocol Identification Number
NCT05625776
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Delaware

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Cognition
Keywords
acute pain, cognition, pain, cognitive ability, young adults

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study 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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain Stimulus
Arm Type
Experimental
Arm Description
Capsaicin combined with heat applied to intact skin
Arm Title
Distractor Somatosensory Stimulus
Arm Type
Active Comparator
Arm Description
Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin
Arm Title
No Stimulus
Arm Type
No Intervention
Arm Description
Nothing applied to skin
Intervention Type
Procedure
Intervention Name(s)
pain delivery with capsaicin and heat
Intervention Description
Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful
Intervention Type
Procedure
Intervention Name(s)
distractor delivery with sensory TENS
Intervention Description
Distractor stimulus delivered (sensory TENS electrical stimulation) that is short-term and attention-demanding but not painful
Intervention Type
Device
Intervention Name(s)
transcutaneous electrical nerve stimulation (TENS)
Intervention Description
transcutaneous electrical nerve stimulation (TENS)
Primary Outcome Measure Information:
Title
Digit Span Forward & Backward Test
Description
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
Time Frame
the change between baseline and delivery (during application of intervention)
Title
Trail Making Test A & B
Description
time required to draw a line connecting a series of numbers (TM-A) or a series of alternating letters and numbers (TM-B)
Time Frame
the change between baseline and delivery (during application of intervention)
Secondary Outcome Measure Information:
Title
Conner's CPT 3
Description
response time for letters vs. 'x' stimuli; number of correct inhibited responses
Time Frame
the change between baseline and delivery (during application of intervention)
Title
Hopkins Verbal Learning Test- Revised
Description
verbal memory for 3 semantic categories of 4 nouns each; immediate and delayed recall
Time Frame
the change between baseline and delivery (during application of intervention)
Title
Brief Visuospatial Memory Test- Revised
Description
visual memory for 6 shapes and their location on a page; immediate and delayed recall and recognition
Time Frame
the change between baseline and delivery (during application of intervention)
Title
Stroop Test
Description
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
Time Frame
the change between baseline and delivery (during application of intervention)
Title
Wisconsin Card Sorting Test
Description
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
Time Frame
the change between baseline and delivery (during application of intervention)
Title
Delis Kaplan Executive Functional System (D-KEFS) - Verbal Fluency Section
Description
number of words stated that match a certain category or start with a certain letter in a given time period
Time Frame
the change between baseline and delivery (during application of intervention)
Title
NIH Toolbox Picture Sequence
Description
reproduce the correct sequence of pictures
Time Frame
the change between baseline and delivery (during application of intervention)
Title
NIH Toolbox Flanker
Description
response time and errors when asked to focus on a single visual stimulus amongst distractors
Time Frame
the change between baseline and delivery (during application of intervention)
Title
NIH Toolbox List Sorting
Description
recall and sequencing of different visually and orally presented stimuli
Time Frame
the change between baseline and delivery (during application of intervention)
Title
NIH Toolbox Dimension Change Card Sort
Description
errors selecting the correct dimension upon which to select a card, a cue for which is provided
Time Frame
the change between baseline and delivery (during application of intervention)
Title
NIH Toolbox Pattern Comparison
Description
errors and time required to determine whether several sets of two pictures are the same or not
Time Frame
the change between baseline and during application of intervention
Title
Wechsler 4th ed - Spatial Addition
Description
errors and time required to add or subtract the location of circles on a screen based on a given set of rules
Time Frame
the change between baseline and delivery (during application of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley Fath
Phone
(302) 283-9936
Email
fath@udel.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne M Morton, PhD
Organizational Affiliation
University of Delaware
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Delaware
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Fath, MS
Phone
302-283-9936
Email
fath@udel.edu

12. IPD Sharing Statement

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Effects of Acute Pain on Cognitive Performance in Young Adults

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