Neurobiological Similarities of Tinnitus and PTSD

Posttraumatic Stress Disorder Clinical Trial

Official title:

An Evaluation of Neurobiological Similarities of Tinnitus and Posttraumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981391
• Other study ID #: HSC20200573HU
• Secondary ID: 5K23MH122579
• Status: Recruiting
• Start date: February 4, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Psychiatric distress caused by PTSD may increase attention toward tinnitus, as well as perceived loudness and discomfort. It is important to understand how tinnitus-related distress and PTSD negatively interact together, in order to develop more effective therapeutic approaches. Understanding symptoms and neurobiological mechanisms using functional magnetic resonance imaging (fMRI), can lead to the necessary knowledge to develop effective interventions for individuals who suffer from both conditions.

Description:

Tinnitus and posttraumatic stress disorder (PTSD) are two of the most common service-connected disabilities for active-duty Service Members and Veterans. Tinnitus and PTSD are highly co-morbid, yet distinct disorders. Tinnitus is an auditory disorder in which an illusory auditory percept is experienced, usually as ringing, buzzing, or whooshing sounds, despite no external objective noise source. On the other hand, PTSD is a trauma-related disorder, and is identified by intrusions of the traumatic event, avoidance of reminders, negative alterations in cognition and mood, and hypervigilance or hyperarousal. Similarities between tinnitus and PTSD have been documented among Cambodian refugees, as well as among U.S. Veteran samples. Moreover, the latest neuroimaging data from a recent clinical trial indicated that the auditory-vigilance network was the most dysregulated among active-duty service members with PTSD, compared to combat controls and civilian controls. Due to similar symptoms between tinnitus-related distress and PTSD, and similar dysregulated resting-state brain networks, it remains important to more fully understand how these two distinct disorders may be related. This study will be the first to prospectively examine the overt emotional, behavioral, and cognitive symptoms related to tinnitus-related distress and PTSD, and the overlapping functional connectivity between tinnitus and PTSD. Investigators will examine the overlapping symptoms and neurobiological mechanisms by conducting audiometric and psychological assessments and resting-state functional magnetic resonance imaging (fMRI) among 120 participants (30 with tinnitus and PTSD, 30 with only PTSD, 30 with only tinnitus, and 30 healthy controls). Participants will be recruited from the Frank Tejeda PTSD Clinic and the Audiology Clinic within the South Texas VA Health Care System, and the Hearing Center of Excellence at Lackland Air Force Base. Canonical correlations will be conducted to examine the symptom overlap between tinnitus and PTSD (Aim 1). Investigators aim to neurobiologically characterize tinnitus and PTSD, both separately and conjointly, by conducting fMRI (Aim 2). Investigators also aim to apply modeling to psychometric and neurofunctional data to identify specific regions of the auditory-vigilance network associated with distress related to tinnitus and PTSD. Understanding the shared cognitive, emotional, and behavioral symptoms and neurobiology associated with tinnitus and PTSD will help clinicians and researchers fully understand tinnitus and PTSD independently and conjointly. Results will lead to the identification of neurobiological markers for tinnitus and PTSD, identification of a different phenotype for individuals with both conditions, and development of behavioral and neuro-modulatory therapies that can reduce distress and impairment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female DEERS eligible veterans and active duty service members, ages 18 and above

• preferred language is English and able to read and speak English at a 6th grade level

• those with PTSD (T&P; PO) must meet full criteria for PTSD diagnosis based on the DSM-5 and assessed by an independent evaluator using the CAPS-5

• those with chronic, constant tinnitus (T&P, TO) will be identified by self-report and confirmed with the audiometric assessment.

Exclusion Criteria:

• psychiatric hospitalization in the last 12 months

• significant cognitive impairment determined by inability to comprehend screening assessment

• psychiatric problems and/or high suicide risk warranting immediate intervention

• neurobiological disorders, Meniere's disease

• Temporomandibular disorders that affect tinnitus, per self-report

• history of major head trauma with loss of consciousness for 20 minutes or more as determined by the History of Head Injuries questionnaire

• history of seizures

• conditions that would prevent completion of fMRI scan (any type of electronic, mechanical, or magnetic implant, coil, filter, or stent, any type of surgical clip or staple, shunt, any type of metal object, hearing aid, spinal fusion, halo vest, IV access port, eyelid spring, artificial eye, artificial heart valve, biostimulator, severe hyperacusis)

• active conductive pathology/hearing loss as determined by audiometric assessment.

• Those with tinnitus (T&P; TO) will be excluded if their tinnitus is intermittent, objective, or pulsatile, or present for less than 6 months.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Tinnitus

Intervention

Diagnostic Test:
• resting-state functional MRI
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)
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.
• Tympanometry
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 Assessment
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.
• Otoscopy
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-conduction
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 testing
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 Discomfort
Loudness discomfort levels will be tested in both right and left ears, from 500Hz to 4000Hz and speech reception threshold.
• Quick Speech in Noise 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)
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).

Locations

Country	Name	City	State
United States	UT Health San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Hearing Center of Excellence, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting-State Functional MRI	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.	30 minutes of acquired data