Pain, AcuteNCT05625776
Effects of Acute Pain on Cognitive Performance in Young Adults
A study testing pain delivery with capsaicin and heat and distractor delivery with sensory TENS in people with Pain, Acute and Cognition, run by University of Delaware at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Cognition
- What is being tested?
- pain delivery with capsaicin and heat and distractor delivery with sensory TENS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2023to 16 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pain, Acute, Cognition
- Being tested
- pain delivery with capsaicin and heat, distractor delivery with sensory TENS
- Keywords
- acute pain, cognition, pain, cognitive ability, young adults
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain delivery with capsaicin and heatProcedure or surgery
Experimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful
distractor delivery with sensory TENSProcedure or surgery
Distractor stimulus delivered (sensory TENS electrical stimulation) that is short-term and attention-demanding but not painful
| Study group | Role | What they receive |
|---|---|---|
| Pain Stimulus | Experimental | Capsaicin combined with heat applied to intact skin Receives: Procedure: pain delivery with capsaicin and heat |
| Distractor Somatosensory Stimulus | Active comparator | Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin Receives: Procedure: distractor delivery with sensory TENS |
| No Stimulus | No intervention | Nothing applied to skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: the change between baseline and delivery (during application of intervention)
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)
Measured: the change between baseline and delivery (during application of intervention)
Secondary outcomes (12)
Conner's Continuous Performance Test (CPT) 3
response time for letters vs. 'x' stimuli; number of correct inhibited responses
Measured: the change between baseline and delivery (during application of intervention)
Hopkins Verbal Learning Test- Revised
verbal memory for 3 semantic categories of 4 nouns each; immediate and delayed recall
Measured: the change between baseline and delivery (during application of intervention)
Brief Visuospatial Memory Test- Revised
visual memory for 6 shapes and their location on a page; immediate and delayed recall and recognition
Measured: the change between baseline and delivery (during application of intervention)
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
Measured: the change between baseline and delivery (during application of intervention)
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
Measured: the change between baseline and delivery (during application of intervention)
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
Measured: the change between baseline and delivery (during application of intervention)
NIH Toolbox Picture Sequence
reproduce the correct sequence of pictures
Measured: the change between baseline and delivery (during application of intervention)
NIH Toolbox Flanker
response time and errors when asked to focus on a single visual stimulus amongst distractors
Measured: the change between baseline and delivery (during application of intervention)
NIH Toolbox List Sorting
recall and sequencing of different visually and orally presented stimuli
Measured: the change between baseline and delivery (during application of intervention)
NIH Toolbox Dimension Change Card Sort
errors selecting the correct dimension upon which to select a card, a cue for which is provided
Measured: the change between baseline and delivery (during application of intervention)
NIH Toolbox Pattern Comparison
errors and time required to determine whether several sets of two pictures are the same or not
Measured: the change between baseline and during application of intervention
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
Measured: the change between baseline and delivery (during application of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start22 Mar 2023
- Primary completion16 Nov 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Susanne M Morton, University of Delaware
- Investigators
- Susanne M Morton, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625776
- Sponsor's protocol ID
- 1786370-1.2
- Other IDs
- R01AG071585
- Status last verified
- Dec 2023
- First submitted
- 13 Nov 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Pain on Cognitive Performance in Young Adults
- ClinicalTrials.gov ID
- NCT05625776
- Acronym / sponsor ID
- 1786370-1.2
- Conditions
- Pain, Acute, Cognition
- Keywords
- acute pain, cognition, pain, cognitive ability, young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 16 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pain Stimulus | Experimental | Procedure: pain delivery with capsaicin and heatCapsaicin combined with heat applied to intact skin |
| Distractor Somatosensory Stimulus | Active comparator | Procedure: distractor delivery with sensory TENSSensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin |
| No Stimulus | No intervention | –Nothing applied to skin |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain delivery with capsaicin and heatExperimental pain paradigm delivered (capsaicin cream combined with heat) that is short-term and painful but not harmful | Procedure or surgery | Pain Stimulus |
| distractor delivery with sensory TENSDistractor stimulus delivered (sensory TENS electrical stimulation) that is short-term and attention-demanding but not painful | Procedure or surgery | Distractor Somatosensory Stimulus |
Primary outcome
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
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)
12 secondary outcomes
Conner's Continuous Performance Test (CPT) 3
Time frame: the change between baseline and delivery (during application of intervention)
Hopkins Verbal Learning Test- Revised
Time frame: 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)
Stroop Test
Time frame: 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)
Delis Kaplan Executive Functional System (D-KEFS) - Verbal Fluency Section
Time frame: 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)
NIH Toolbox Flanker
Time frame: 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)
NIH Toolbox Dimension Change Card Sort
Time frame: 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
Wechsler 4th ed - Spatial Addition
Time frame: the change between baseline and delivery (during application of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne M Morton, PhD principal investigator
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pain delivery with capsaicin and heat and distractor delivery with sensory TENS in people with Pain, Acute and Cognition, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digit Span Forward & Backward Test (time frame: the change between baseline and delivery (during application of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.