Effects of Acute Pain on Cognitive Performance in Young Adults

December 4, 2023 updated by: Susanne M Morton, University of Delaware
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ashley Fath
  • Phone Number: (302) 283-9936
  • Email: fath@udel.edu

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • University of Delaware

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: No Stimulus
Nothing applied to skin
Experimental: Pain Stimulus
Capsaicin combined with heat applied to intact skin
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
Active Comparator: Distractor Somatosensory Stimulus
Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin
Procedure: distractor delivery with sensory TENS
Distractor stimulus delivered (sensory TENS electrical stimulation) that is short-term and attention-demanding but not painful

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Digit Span Forward & Backward Test
Time Frame: the change between baseline and delivery (during application of intervention)
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 Frame: the change between baseline and delivery (during application of intervention)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hopkins Verbal Learning Test- Revised
Time Frame: the change between baseline and delivery (during application of intervention)
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
Time Frame: the change between baseline and delivery (during application of intervention)
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
Time Frame: the change between baseline and delivery (during application of intervention)
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
Time Frame: the change between baseline and delivery (during application of intervention)
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
Time Frame: the change between baseline and delivery (during application of intervention)
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
Time Frame: the change between baseline and delivery (during application of intervention)
reproduce the correct sequence of pictures
the change between baseline and delivery (during application of intervention)
NIH Toolbox Flanker
Time Frame: the change between baseline and delivery (during application of intervention)
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
Time Frame: the change between baseline and delivery (during application of intervention)
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
Time Frame: the change between baseline and delivery (during application of intervention)
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
Time Frame: the change between baseline and during application of intervention
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
Time Frame: the change between baseline and delivery (during application of intervention)
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)
Conner's Continuous Performance Test (CPT) 3
Time Frame: the change between baseline and delivery (during application of intervention)
response time for letters vs. 'x' stimuli; number of correct inhibited responses
the change between baseline and delivery (during application of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Delaware

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susanne M Morton, PhD, University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1786370-1.2
  • R01AG071585 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings