Mobile Acoustic Startle Reflex-monitoring System (MARS)

PTSD Clinical Trial

Official title:

Mobile Acoustic Startle Reflex-monitoring System (MARS): A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113850
• Other study ID #: IRB00217977
• Status: Completed
• Phase: N/A
• Start date: November 28, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study of 55 adult male veterans with PTSD. The study will test a new mobile application "app" that can be run on an iPhone10. The app, which is called the Mobile Acoustic startle Reflex-monitoring System (a.k.a., MARS), will be used to measure participant's acoustic startle in sitting or standing postures.

Description:

The proposed study utilizes a randomized, controlled between-subjects design that will compare and contrast MARS data collected in the sitting versus standing position, and will determine the relationship between PTSD severity and MARS outcome measures. Fifty-five subjects will be recruited from Johns Hopkins and VA facilities, International Association of Fire Fighters Center of Excellence, Veteran Centers in Baltimore/District of Columbia/Northern Virginia area, as well as the Florida panhandle and through social media venues. When potential participants respond to advertisements, study coordinators will explain the purpose of the study and study procedures by phone before arranging a face-to-face meeting with the research team. Once a potential participant indicates willingness to participate, a study team member will meet with the participant at the their residence, or at the Johns Hopkins Bayview Medical Center, where the consent document will be reviewed and MARS testing will take place. Recruitment will continue until a total of 55 participants have been consented.

Volunteers shall sign a participation waiver acknowledging the inclusion/exclusion criteria and will be verbally briefed about the experimental proceedings. After consent procedures are complete, volunteers will provide a saliva sample and breathalyzer for "on the spot" drug screens. If drug screens are negative for sedatives and stimulants (both of which can alter the acoustic startle response), research volunteers will be interviewed using the Structured Interview for PTSD (SI-PTSD).

After completing the SI-PTSD (and it is clear that the subject meets criteria for PTSD), the subject will be be instructed to don earphones as well as noise insulating earmuffs. The MARS evaluation will then proceed in either a sitting or standing position, and the sound stimuli will be conducted at two frequencies [500 and 4000 Hertz (Hz)] at three volumes [65, 90, and 105 decibels (dBs)] for a total of 12 acoustic test sets, in random order. The MARS shall record both left and right eye reactions to each of these 12 acoustic/posture sets. The MARS protocol shall be administered for approximately 6 minutes while the volunteer is sitting/standing quietly and looking forward at the mobile device (which will be located approximately 60 centimeters away).

Within 3 weeks of MARS measurements, the study psychiatrist will conduct a private interview with the participant via remote video. The study psychiatrist (Dr. McCann), who will be blind to MARS data, will interview subjects using the Clinician-Administered PTSD Scale for the Diagnostic and Statistical Manual-5 (DSM-5) (CAPS-5).

Investigators will determine the statistical relationship between PTSD severity (as measured on a numerical scale from 1-5) and eye blink parameters. All data points will be entered into machine learning software (a.k.a. deep learning software) both to analyze interconnections between outcome measures and PTSD severity, but also to make predictions for future studies in PTSD patients evaluated using the MARS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of PTSD

Exclusion Criteria:

• positive drug or alcohol screen

Related Conditions & MeSH terms

• PTSD

Intervention

Device:
• Mobile Acoustic startle Reflex monitoring System (MARS)
Acoustic startle testing

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	DigiTheronix, School of Biomedical Sciences, University of Otago, Dunedin, New Zealand

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship between acoustic startle reflex and PTSD severity	The statistical correlation between acoustic startle response (both time and amplitude) and PTSD severity (as measured on a scale from 1 to 5) will be determined. In particular, individuals' average acoustic startle responses to each of the 12 stimuli parameters will be correlated with their PTSD severity. All 55 subjects will be included in these correlational analyses.	1 year after the initiation of enrollment
Primary	Acoustic Startle Response (speed)	The acoustic startle response is the physiological measurement of eye-blink reflex following a sound. In the present protocol, various intensities of sound will be played using specialized equipment that plays sound through noise-cancelling earphones. The acoustic startle measure will be obtained using an "App" on an Apple iPhone 10. The primary startle response outcome is the time in seconds (typically milliseconds) between the playing of the sound, and the individual's eyeblink.	1 year after initiation of enrollment
Secondary	Acoustic Startle Response (amplitude)	The acoustic startle response amplitude is a secondary outcome, and is defined as the maximal excursion of eye size from resting eye size, measured metrically (typically millimeters).	1 year after the initiation of enrollment