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CompletedNCT04058184Updated Aug 15, 2019

Prepulse Inhibition in Youth Contact Sports Players

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
13 Years to 19 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Reflex, Abnormal

Browse trials for

Keywords

  • Prepulse Inhibition
  • Startle Response
03

In context

Reflex, Abnormal

18 studies on the registry are indexed under Reflex, Abnormal; 1 is open to participants now.

Browse Reflex, Abnormal studies →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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

Exclusion Criteria:

  • Subjects on psychostimulant, antidepressant, or anxiolytic medications, as well as subjects who have experienced hearing loss, will not be eligible to participate.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Startle Magnitute

    collected from each participant's raw EMG data

    Time frame: baseline

  2. Startle Magnitute

    collected from each participant's raw EMG data

    Time frame: startle test up to 1 hr from baseline

  3. Startle Probability

    collected from each participant's raw EMG data

    Time frame: baseline

  4. Startle Probability

    collected from each participant's raw EMG data

    Time frame: startle test up to 1 hr from baseline

  5. Percentage of Prepulse Inhibition

    collected from each participant's raw EMG data

    Time frame: baseline test

  6. Percentage of Prepulse Inhibition

    collected from each participant's raw EMG data

    Time frame: startle test up to 1 hr from baseline

Secondary outcomes

  1. Reaction Time

    data collected from applicable subject's response pad

    Time frame: baseline test

  2. Reaction Time

    data collected from applicable subject's response pad

    Time frame: startle test up to 1 hr from baseline

  3. Accuracy Measures

    data collected from applicable subject's response pad

    Time frame: baseline test

  4. Accuracy Measures

    data collected from applicable subject's response pad

    Time frame: startle test up to 1 hr from baseline

07

Study locations

1 site
  • Wake Forest University
    Winston-Salem, North Carolina 27109, United States
08

References and documents

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. PubMed 26283146 ↗
  • 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. PubMed 25234706 ↗
  • 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. PubMed 25532594 ↗
  • 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. PubMed 18702584 ↗
  • 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. PubMed 15804447 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2018 to primary completion in May 2019, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2019
First posted
Aug 15, 2019
StartActual
Jul 9, 2018
Primary completionActual
May 17, 2019
CompletionActual
May 17, 2019
Last update
Aug 15, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04058184
Responsible party
Sponsor
First posted
Aug 15, 2019
Start date
Jul 9, 2018
Primary completion
May 17, 2019
Completion
May 17, 2019
Last update
Aug 15, 2019

Study contacts

Blumenthal
principal investigator · Wake Forest University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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