Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04058184
Status:
COMPLETED
Last Update Posted:
2019-08-15
First Post:
2019-08-08
Brief Title:
Prepulse Inhibition in Youth Contact Sports Players
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Prepulse Inhibition of the Startle Response in Youth Contact Sports Players
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The studys main research question will be investigating whether or not there is a significant difference in Prepulse Inhibition PPI as well as startle response probability and magnitude between contact and noncontact youth sports players The study team will test these questions using a controlled laboratory scenario in which the presentation of startle stimuli can be observed measured and quantified in order to compare the results between the two sample populations During preliminary testing the study team can predict that there will be no significant differences between contact sports players and noncontact sports players in their startle reactivity and level of exhibited PPI Based on previous literature the study team hypothesizes that those in the contact sports group will experience greater startle reactivity and less PPI than those in the noncontact sports group when they are tested at the end of their sports season Using this information the present study will allow for additional understanding of the neurological and physiological behaviors associated with subconcussive head impacts
This study will assess and determine whether prepulse inhibition in youth contact sports players and non-contact sports players both before and after a sports season will significantly differ Measures will include the startle magnitude startle probability reaction time and accuracy of tone detection responses
This study will assess and determine whether prepulse inhibition in youth contact sports players and non-contact sports players both before and after a sports season will significantly differ Measures will include the startle magnitude startle probability reaction time and accuracy of tone detection responses
Detailed Description:
Our main research question will be investigating whether or not there is a significant difference in PPI as well as startle response probability and magnitude between contact and noncontact youth sports players The study team will test these questions using a controlled laboratory scenario in which the presentation of startle stimuli can be observed measured and quantified in order to compare the results between the two sample populations During preliminary testing the study team can predict that there will be no significant differences between contact sports players and noncontact sports players in their startle reactivity and level of exhibited PPI Based on previous literature the study team hypothesizes that those in the contact sports group will experience greater startle reactivity and less PPI than those in the noncontact sports group when they are tested at the end of their sports season Using this information the present study will allow for additional understanding of the neurological and physiological behaviors associated with subconcussive head impacts
This study will assess and determine whether prepulse inhibition in youth contact sports players and non-contact sports players both before and after a sports season will significantly differ Measures will include the startle magnitude startle probability reaction time and accuracy of tone detection responses
The current study is a case-control study examining the contact sports players as the testing sample and the noncontact sports players as the control sample
Participants will arrive and hear an introduction of the study
Participants and their parentguardian if under the age of 18 will read and sign an informed consent andor informed assent form
Participants will complete a series of questionnaires prior to electrode placement
The Health History Questionnaire will be completed first to determine participant eligibility
The STAI will be completed next to be used for further analysis in the data compilation
Participants will have three electrodes placed on the skin
Two electrodes will be placed underneath the left eye as the nasal and temporal electrodes
One electrode will be placed on the left temple as the ground electrode
These electrodes connect to the Biopac apparatus the software that measures the participants EMG activity
The procedure of the study will be thoroughly explained to the participants They will be instructed to wear headphones that will deliver the acoustic startle stimuli and to remain as still and quiet as possible during the startle blocks
There will be a total of two startle blocks baseline and testing
The baseline startle block will consist of a combination of prepulses at 70 decibels of 800 and 1000 Hz frequency tones for a duration of 30 milliseconds presented with an onset of 120 milliseconds prior to the presentation of the startle stimulus of 100 decibels of broadband noise for 50 milliseconds on some trials
The testing block will also consist of prepulses at 70 decibels of 800 and 1000 Hz frequency tones for a duration of 30 milliseconds presented with an onset of 120 milliseconds prior to the presentation of the startle stimulus of 100 decibels of broadband noise for 50 milliseconds on some trials For the testing block participants will be asked to respond on a keypad when they hear the lower prepulse tone of 800 Hz
Startle stimuli will be presented via headphones Startle stimuli will be presented from the Superlab software program which will run from the testing room
After the testing block the electrodes will be removed from the participants skin
Participants will be thoroughly debriefed on the aims of the current study
This study will take place in the MRI suite of Wake Forest Baptist Health A single room within the suite will be designated for the PPI testing in order to control for external noise factors
After the consent process subjects will be asked to fill out a brief health history questionnaire This is for the purpose of determining the subjects eligibility to participate in the study Subjects will also be asked to complete an STAI form and this will be used later during data analysis
This study will last approximately one hour The introduction and consent process will take about 10 minutes The questionnaire process is expected to take about 10 minutes The application of sensors should take about 10 minutes The testing process including the explanation of both startle blocks should last about 20 minutes The sensor removal and debriefing process will last about 10 minutes
This study will assess and determine whether prepulse inhibition in youth contact sports players and non-contact sports players both before and after a sports season will significantly differ Measures will include the startle magnitude startle probability reaction time and accuracy of tone detection responses
The current study is a case-control study examining the contact sports players as the testing sample and the noncontact sports players as the control sample
Participants will arrive and hear an introduction of the study
Participants and their parentguardian if under the age of 18 will read and sign an informed consent andor informed assent form
Participants will complete a series of questionnaires prior to electrode placement
The Health History Questionnaire will be completed first to determine participant eligibility
The STAI will be completed next to be used for further analysis in the data compilation
Participants will have three electrodes placed on the skin
Two electrodes will be placed underneath the left eye as the nasal and temporal electrodes
One electrode will be placed on the left temple as the ground electrode
These electrodes connect to the Biopac apparatus the software that measures the participants EMG activity
The procedure of the study will be thoroughly explained to the participants They will be instructed to wear headphones that will deliver the acoustic startle stimuli and to remain as still and quiet as possible during the startle blocks
There will be a total of two startle blocks baseline and testing
The baseline startle block will consist of a combination of prepulses at 70 decibels of 800 and 1000 Hz frequency tones for a duration of 30 milliseconds presented with an onset of 120 milliseconds prior to the presentation of the startle stimulus of 100 decibels of broadband noise for 50 milliseconds on some trials
The testing block will also consist of prepulses at 70 decibels of 800 and 1000 Hz frequency tones for a duration of 30 milliseconds presented with an onset of 120 milliseconds prior to the presentation of the startle stimulus of 100 decibels of broadband noise for 50 milliseconds on some trials For the testing block participants will be asked to respond on a keypad when they hear the lower prepulse tone of 800 Hz
Startle stimuli will be presented via headphones Startle stimuli will be presented from the Superlab software program which will run from the testing room
After the testing block the electrodes will be removed from the participants skin
Participants will be thoroughly debriefed on the aims of the current study
This study will take place in the MRI suite of Wake Forest Baptist Health A single room within the suite will be designated for the PPI testing in order to control for external noise factors
After the consent process subjects will be asked to fill out a brief health history questionnaire This is for the purpose of determining the subjects eligibility to participate in the study Subjects will also be asked to complete an STAI form and this will be used later during data analysis
This study will last approximately one hour The introduction and consent process will take about 10 minutes The questionnaire process is expected to take about 10 minutes The application of sensors should take about 10 minutes The testing process including the explanation of both startle blocks should last about 20 minutes The sensor removal and debriefing process will last about 10 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None