- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04113850
Mobile Acoustic Startle Reflex-monitoring System (MARS)
Mobile Acoustic Startle Reflex-monitoring System (MARS): A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diagnosis of PTSD
Exclusion Criteria:
- positive drug or alcohol screen
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sitting
Subjects will undergo acoustic startle testing in the sitting position.
|
Acoustic startle testing
|
Experimental: Standing
Subjects will undergo acoustic startle testing in the standing position.
|
Acoustic startle testing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acoustic Startle Response (speed)
Time Frame: 1 year after initiation of enrollment
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acoustic Startle Response (amplitude)
Time Frame: 1 year after the initiation of enrollment
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relationship between acoustic startle reflex and PTSD severity
Time Frame: 1 year after the initiation of enrollment
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Una McCann, MD, Johns Hopkins University
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
Other Study ID Numbers
- IRB00217977
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Analytic Code
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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