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Acute Pain's Impact on Cognitive Performance
N/A
Waitlist Available
Led By Susanne M Morton, PhD
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the change between baseline and delivery (during application of intervention)
Awards & highlights
Summary
This trial aims to understand how sudden pain affects thinking skills like memory, attention, and speed of processing information. Researchers will study people in pain to see if it makes these mental tasks harder.
Eligible Conditions
- Cognition
- Acute Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the change between baseline and delivery (during application of intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the change between baseline and delivery (during application of intervention)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Digit Span Forward & Backward Test
Trail Making Test A & B
Secondary study objectives
Brief Visuospatial Memory Test- Revised
Conner's Continuous Performance Test (CPT) 3
Delis Kaplan Executive Functional System (D-KEFS) - Verbal Fluency Section
+9 moreSide effects data
From 2016 Phase 4 trial • 120 Patients • NCT0312440765%
Application site pain
18%
Application site pruritus
3%
Application site erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
QD-Active
QD-Vehicle
BID-Active
BID-Vehicle
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Pain StimulusExperimental Treatment1 Intervention
Capsaicin combined with heat applied to intact skin
Group II: No StimulusActive Control1 Intervention
Nothing applied to skin
Group III: Distractor Somatosensory StimulusActive Control1 Intervention
Sensory transcutaneous electrical nerve stimulation (TENS) applied to intact skin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pain delivery with capsaicin and heat
2023
N/A
~30
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,980 Total Patients Enrolled
4 Trials studying Cognition
2,810 Patients Enrolled for Cognition
University of DelawareLead Sponsor
161 Previous Clinical Trials
25,673 Total Patients Enrolled
Susanne M Morton, PhDPrincipal InvestigatorUniversity of Delaware
2 Previous Clinical Trials
129 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of or currently have mental health conditions, learning disabilities, or cognitive impairments like severe anxiety, severe depression, or autism spectrum disorder.Your score on the MoCA test is less than 23.Your resting heart rate is either too slow (less than 50 beats per minute) or too fast (more than 100 beats per minute).Your resting blood pressure is too low (less than 90/60) or too high (more than 140/95).You are currently taking four or more medications.Your score on the GAD-7 anxiety questionnaire is 10 or higher.You have a score of 2 or more on the PHQ-2 and a score of 10 or more on the PHQ-9.You have had ongoing health issues in the past three months, including problems with muscles and bones, the heart, hormones, lungs, metabolism, mental health, or the nervous system.You have a medical device like a pacemaker or neurostimulator implanted in your body.You have sensitive skin that reacts to soaps, creams, perfumes, or heat.You have taken part in a study about movement and learning in this lab in the last 2 years.You are between 18 and 35 years old.You are allergic to spicy foods or hot peppers.You have reduced feeling or strength in your legs or in the area being tested.You have a history of balance problems, dizziness, or more than one fall in the past year.You have had a severe head injury where you lost consciousness for more than 5 minutes or needed medical treatment, or you have had more than 2 concussions in your life.You are currently taking pain relief medications regularly, including over-the-counter remedies.You have poor blood flow in the area where the pain will be tested.You have had ongoing pain anywhere in your body for the past year.You have any skin issues in the area where the pain will be tested.
Research Study Groups:
This trial has the following groups:- Group 1: Pain Stimulus
- Group 2: No Stimulus
- Group 3: Distractor Somatosensory Stimulus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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