- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04058184
Prepulse Inhibition in Youth Contact Sports Players
Prepulse Inhibition of the Startle Response in Youth Contact Sports Players
The study's 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.
Study Overview
Status
Conditions
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 parent/guardian if under the age of 18) will read and sign an informed consent and/or 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 participant's 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 participant's 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 subject's 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27109
- Wake Forest University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
• Participants are specifically recruited for this study due to their involvement on a sports team that may or may not expose them to head impacts.
Exclusion Criteria:
• Subjects on psychostimulant, antidepressant, or anxiolytic medications, as well as subjects who have experienced hearing loss, will not be eligible to participate.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Contact sports players
Athletes who engage in contact sports, football for example.
Participation in this study will involve listening to sudden, very brief bursts of noise (startle blocks) and tones, and responding with a keypress to certain tones.
Electromyogram (EMG) will measure the electrical activity generated from movement of the orbicularis oculi muscle during the startle blocks.
|
Non-contact sports players
Athletes who engage in non-contact sports, swimming for example.Participation in this study will involve listening to sudden, very brief bursts of noise (startle blocks) and tones, and responding with a keypress to certain tones.
Electromyogram (EMG) will measure the electrical activity generated from movement of the orbicularis oculi muscle during the startle blocks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Startle Magnitute
Time Frame: baseline
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collected from each participant's raw EMG data
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baseline
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Startle Magnitute
Time Frame: startle test up to 1 hr from baseline
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collected from each participant's raw EMG data
|
startle test up to 1 hr from baseline
|
Startle Probability
Time Frame: baseline
|
collected from each participant's raw EMG data
|
baseline
|
Startle Probability
Time Frame: startle test up to 1 hr from baseline
|
collected from each participant's raw EMG data
|
startle test up to 1 hr from baseline
|
Percentage of Prepulse Inhibition
Time Frame: baseline test
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collected from each participant's raw EMG data
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baseline test
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Percentage of Prepulse Inhibition
Time Frame: startle test up to 1 hr from baseline
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collected from each participant's raw EMG data
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startle test up to 1 hr from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaction Time
Time Frame: baseline test
|
data collected from applicable subject's response pad
|
baseline test
|
Reaction Time
Time Frame: startle test up to 1 hr from baseline
|
data collected from applicable subject's response pad
|
startle test up to 1 hr from baseline
|
Accuracy Measures
Time Frame: baseline test
|
data collected from applicable subject's response pad
|
baseline test
|
Accuracy Measures
Time Frame: startle test up to 1 hr from baseline
|
data collected from applicable subject's response pad
|
startle test up to 1 hr from baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Blumenthal, Wake Forest University
Publications and helpful links
General Publications
- Blumenthal TD. Presidential Address 2014: The more-or-less interrupting effects of the startle response. Psychophysiology. 2015 Nov;52(11):1417-31. doi: 10.1111/psyp.12506. Epub 2015 Aug 18.
- Blumenthal TD, Reynolds JZ, Spence TE. Support for the interruption and protection hypotheses of prepulse inhibition of startle: evidence from a modified Attention Network Test. Psychophysiology. 2015 Mar;52(3):397-406. doi: 10.1111/psyp.12334. Epub 2014 Sep 19.
- Washington JR, Blumenthal TD. Effects of a startle stimulus on response speed and inhibition in a go/no-go task. Psychophysiology. 2015 Jun;52(6):745-53. doi: 10.1111/psyp.12400. Epub 2014 Dec 23.
- Jepma M, Wagenmakers EJ, Band GP, Nieuwenhuis S. The effects of accessory stimuli on information processing: evidence from electrophysiology and a diffusion model analysis. J Cogn Neurosci. 2009 May;21(5):847-64. doi: 10.1162/jocn.2009.21063.
- Thorne GL, Dawson ME, Schell AM. Attention and prepulse inhibition: the effects of task-relevant, irrelevant, and no-task conditions. Int J Psychophysiol. 2005 May;56(2):121-8. doi: 10.1016/j.ijpsycho.2004.11.006. Epub 2005 Jan 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00051757
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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