Neurobiological Similarities of Tinnitus and PTSD

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Study population: This study will consent and screen veterans and active duty service members to include 120 for analysis. Subjects will be recruited from the San Antonio community. Women and minorities will be actively recruited into the study.

Trial locations and contacts

1 site in 1 country.

About this study

Official title: An Evaluation of Neurobiological Similarities of Tinnitus and Posttraumatic Stress Disorder

Conditions

Posttraumatic Stress Disorder, Tinnitus

Being tested

resting-state functional MRI, Clinician Administered PTSD Scale for the DSM-5 (CAPS-5), Tympanometry, Tinnitus Assessment, Otoscopy

Keywords

resting-state fMRI, PTSD, tinnitus, military, veterans

Medical subject headings

Stress Disorders, Post-Traumatic, Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• resting-state functional MRIDiagnostic test

  We will acquire BOLD fMRI images in an unstimulated state using an extended time-series (300 whole-brain volumes over ~ 60-75 min). These data are a main outcome. Data will be processed on an ongoing basis to ensure integrity, and includes controlling for white matter, cerebral spinal fluid, and movement.

• Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)Diagnostic test

  The CAPS-5 is a semi-structured interview, conducted by an independent evaluator, that measures DSM-5 symptoms of PTSD. Presence of at least one intrusion symptom, one avoidance symptom, two cognition and mood symptoms, and two arousal symptoms for 1 month or more are required to reach the diagnostic threshold.

• TympanometryDiagnostic test

  Tympanometry will be conducted to assess ear canal volume (cm cubed), maximum pressure (daPa) peak compliance (ml), and type (A, AD, AS, B, B-High, C) for each ear) at 226-Hz admittance.

• Tinnitus AssessmentDiagnostic test

  Tinnitus acoustic assessment (for tinnitus participants only): Tinnitus ear (left, right, bilateral), pitch matched frequency (Hz) and loudness matched intensity (dB) will be conducted. When available, the tinnitus acoustic assessment only will be repeated at the RII, on the same day and prior to the fMRI scan, to demonstrate reproducibility of results.

• OtoscopyDiagnostic test

  Otoscopy is a clinical procedure used to examine structures of the ear, particularly the external auditory canal, tympanic membrane, and middle ear

• Pure tone air and bone-conductionDiagnostic test

  Pure tone air- and bone-conduction threshold will be conducted to evaluate audiometry and masking levels in both ears, from 250 Hz. To 16000 Hz.

• Speech testingDiagnostic test

  Speech testing will be conducted in both ears, which will include speech reception threshold, speech reception threshold masking level, word recognition presentation level, and word recognition masking level.

• Loudness DiscomfortDiagnostic test

  Loudness discomfort levels will be tested in both right and left ears, from 500Hz to 4000Hz and speech reception threshold.

• Quick Speech in Noise TestDiagnostic test

  Quick Speech in Noise Test (QuickSIN) is a quick method for clinicians to quantify a patient's ability to hear in noise (1 minute).

• Distortion-Product Otoacoustic Emissions (DPOAE)Diagnostic test

  Distortion-Product Otoacoustic Emissions (DPOAE) is an automated evaluation of cochlear function. A sensitive microphone is placed in the ear canal via a probe assembly with a disposable ear-tip attached to perform and record the measurements. DPOAEs will be elicited at multiple frequencies in both ears (10 min).

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Resting-State Functional MRI

   We will acquire BOLD fMRI images in an unstimulated state using an extended time-series (300 whole-brain volumes over ~ 30 min) and assess for activation within the Auditory Vigilance Network. These data are a main outcome. Data were be processed on an ongoing basis to ensure integrity, and includes controlling for white matter, cerebral spinal fluid, and movement.

   BOLD levels were transformed to Z-scores, a statistical measure that conveys how many standard deviations the data points are away from the dataset. A Z-score of 0 represents the population mean. For each of the regions reported in the Auditory Vigilance Network, each positive point represents one standard deviation above the population mean. These positive Z-scores represent more brain activation within these regions.

   Measured: 30 minutes of acquired data

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted8 Aug 2023
2. Study start4 Feb 2021
3. Primary completion1 Nov 2024
4. Study completion1 Nov 2024

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
• More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.