NCT04058184

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
Last Updated

August 15, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

August 8, 2019

Last Update Submit

August 13, 2019

Conditions

Keywords

Prepulse InhibitionStartle Response

Outcome Measures

Primary Outcomes (6)

  • Startle Magnitute

    collected from each participant's raw EMG data

    baseline

  • Startle Magnitute

    collected from each participant's raw EMG data

    startle test up to 1 hr from baseline

  • Startle Probability

    collected from each participant's raw EMG data

    baseline

  • Startle Probability

    collected from each participant's raw EMG data

    startle test up to 1 hr from baseline

  • Percentage of Prepulse Inhibition

    collected from each participant's raw EMG data

    baseline test

  • Percentage of Prepulse Inhibition

    collected from each participant's raw EMG data

    startle test up to 1 hr from baseline

Secondary Outcomes (4)

  • Reaction Time

    baseline test

  • Reaction Time

    startle test up to 1 hr from baseline

  • Accuracy Measures

    baseline test

  • Accuracy Measures

    startle test up to 1 hr from baseline

Study Arms (2)

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.

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants who participate on a sports team who range in age from 13 to 19.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

Location

Related Publications (5)

  • 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.

    PMID: 26283146BACKGROUND
  • 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.

    PMID: 25234706BACKGROUND
  • 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.

    PMID: 25532594BACKGROUND
  • 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.

    PMID: 18702584BACKGROUND
  • 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.

    PMID: 15804447BACKGROUND

MeSH Terms

Conditions

Reflex, Abnormal

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Blumenthal

    Wake Forest University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 15, 2019

Study Start

July 9, 2018

Primary Completion

May 17, 2019

Study Completion

May 17, 2019

Last Updated

August 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations