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Thermal Pain's Impact on Cognitive Functioning Using iPad Game
N/A
Recruiting
Led By Douglas Ririe, MD, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy male and non-pregnant female volunteers between the ages of 18-55.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 minutes
Awards & highlights
Study Summary
This trial will study how well people can think and concentrate after experiencing thermal (cold or warm) pain, using an iPad game.
Who is the study for?
This trial is for healthy men and non-pregnant women aged 18-55 who can play an iPad game. It's not for those with cold sensitivity issues, learning disabilities, psychomotor impairments like ADD/ADHD, seizures, serious neurological or genetic diseases, heart disease, stroke, memory problems, or physical limitations affecting the hands or eyes.Check my eligibility
What is being tested?
Researchers are testing how pain affects attention by having participants play a special iPad game before, during and after being exposed to controlled heat or cold pain stimuli. Some will have no intervention as a control group.See study design
What are the potential side effects?
There may be temporary discomfort from the heat or cold used to induce pain during the study. No significant side effects are expected from playing the iPad game itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy adult between 18 and 55 years old and not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median cue duration
Secondary outcome measures
Number of omitted responses
Premature discontinuation of game
number correct
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Thermal pain and ipad performanceExperimental Treatment3 Interventions
Interventions: Cold induced pain and heat induced pain. The whole group gets thermal heat (n=40) and half (n=20) get cold water foot immersion and half (n=20) get body temperature foot emersion. The person will be instructed how to hold the iPad and how to play the game. The person will then be allowed to play the game until the number of trials is completed or until the person no longer wishes to play.
Group II: No Intervention Game playActive Control1 Intervention
The person will be instructed how to hold the iPad and how to play the game.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iPad
2017
N/A
~1130
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,177 Total Patients Enrolled
1 Trials studying Cognitive Functioning
73 Patients Enrolled for Cognitive Functioning
Douglas Ririe, MD, PhDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart disease.I have had a stroke.I have a severe neurological condition like MS or muscular dystrophy.I have a genetic disease.I can hold an iPad and play games on it without issues.I have cold agglutinins or Raynaud's disease.I have been diagnosed with ADD/ADHD or have psychomotor impairment.I have seizures.I am a healthy adult between 18 and 55 years old and not pregnant.I do not feel cold easily.
Research Study Groups:
This trial has the following groups:- Group 1: Thermal pain and ipad performance
- Group 2: No Intervention Game play
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the cohort under evaluation in this trial?
"Yes, according to clinicaltrials.gov this medical experiment is actively recruiting; it was initially posted on May 15th 2016 and amended recently on September 28th 2022. The trial necessitates 60 participants from a single site."
Answered by AI
Who is an eligible candidate for participation in this clinical experiment?
"To qualify for this clinical trial, volunteers should be between 18 and 55 years old with good cognitive functioning. The total number of participants needed is 60 individuals."
Answered by AI
Is this research program currently recruiting participants?
"Clinicaltrials.gov confirms that this medical study, which was initially made available on the 15th of May 2016, is actively recruiting participants. The trial has been updated most recently on the 28th September 2022."
Answered by AI
Does this trial accept minors as participants?
"This trial is restricted to those between 18 and 55 years old. Individuals below the age of consent must look for one study, whereas seniors can access 11 different trials."
Answered by AI
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