An observational study in Reflex, Abnormal, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-15.
Sponsored by Wake Forest University Health Sciences · Observational
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.
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 complete a series of questionnaires prior to electrode placement.
Participants will have three electrodes placed on the skin.
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.
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.
18 studies on the registry are indexed under Reflex, Abnormal; 1 is open to participants now.
Browse Reflex, Abnormal studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
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Participants who participate on a sports team who range in age from 13 to 19.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Startle Magnitute
collected from each participant's raw EMG data
Time frame: baseline
Startle Magnitute
collected from each participant's raw EMG data
Time frame: startle test up to 1 hr from baseline
Startle Probability
collected from each participant's raw EMG data
Time frame: baseline
Startle Probability
collected from each participant's raw EMG data
Time frame: startle test up to 1 hr from baseline
Percentage of Prepulse Inhibition
collected from each participant's raw EMG data
Time frame: baseline test
Percentage of Prepulse Inhibition
collected from each participant's raw EMG data
Time frame: startle test up to 1 hr from baseline
Reaction Time
data collected from applicable subject's response pad
Time frame: baseline test
Reaction Time
data collected from applicable subject's response pad
Time frame: startle test up to 1 hr from baseline
Accuracy Measures
data collected from applicable subject's response pad
Time frame: baseline test
Accuracy Measures
data collected from applicable subject's response pad
Time frame: startle test up to 1 hr from baseline
Plan to share: No
Ran from Jul 2018 to primary completion in May 2019, 10 months.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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