Neurobiological Similarities of Tinnitus and PTSD

Completed

• Conditions: Posttraumatic Stress Disorder; Tinnitus
• Interventions: Diagnostic Test: resting-state functional MRI; Diagnostic Test: Clinician Administered PTSD Scale for the DSM-5 (CAPS-5); Diagnostic Test: Tympanometry; Diagnostic Test: Otoscopy; Diagnostic Test: Tinnitus Assessment; Diagnostic Test: Pure tone air and bone-conduction; Diagnostic Test: Loudness Discomfort; Diagnostic Test: Speech testing; Diagnostic Test: Quick Speech in Noise Test; Diagnostic Test: Distortion-Product Otoacoustic Emissions (DPOAE)

• Registration Number: NCT05981391
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-02-04
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-08
• Status Verified: 2024-11
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tinnitus and PTSD (T+P)	resting-state functional MRI	Active duty service members and/or veterans with PTSD and tinnitus.
Tinnitus and PTSD (T+P)	Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)	Active duty service members and/or veterans with PTSD and tinnitus.
Tinnitus and PTSD (T+P)	Pure tone air and bone-conduction	Active duty service members and/or veterans with PTSD and tinnitus.
Tinnitus Only (TO)	Otoscopy	Active duty service members and/or veterans with only tinnitus/no PTSD.
Tinnitus and PTSD (T+P)	Tympanometry	Active duty service members and/or veterans with PTSD and tinnitus.
Tinnitus Only (TO)	Distortion-Product Otoacoustic Emissions (DPOAE)	Active duty service members and/or veterans with only tinnitus/no PTSD.
Tinnitus and PTSD (T+P)	Tinnitus Assessment	Active duty service members and/or veterans with PTSD and tinnitus.
Tinnitus and PTSD (T+P)	Otoscopy	Active duty service members and/or veterans with PTSD and tinnitus.
Tinnitus and PTSD (T+P)	Speech testing	Active duty service members and/or veterans with PTSD and tinnitus.
PTSD Only (PO)	Tympanometry	Active duty service members and/or veterans with only PTSD/no tinnitus.
Healthy Controls	Speech testing	Active duty service members and/or veterans with no PTSD and no tinnitus.
Healthy Controls	Loudness Discomfort	Active duty service members and/or veterans with no PTSD and no tinnitus.
Tinnitus and PTSD (T+P)	Loudness Discomfort	Active duty service members and/or veterans with PTSD and tinnitus.
Tinnitus and PTSD (T+P)	Distortion-Product Otoacoustic Emissions (DPOAE)	Active duty service members and/or veterans with PTSD and tinnitus.
Tinnitus Only (TO)	resting-state functional MRI	Active duty service members and/or veterans with only tinnitus/no PTSD.
Tinnitus Only (TO)	Tinnitus Assessment	Active duty service members and/or veterans with only tinnitus/no PTSD.
Tinnitus Only (TO)	Pure tone air and bone-conduction	Active duty service members and/or veterans with only tinnitus/no PTSD.
Tinnitus Only (TO)	Speech testing	Active duty service members and/or veterans with only tinnitus/no PTSD.
Tinnitus Only (TO)	Quick Speech in Noise Test	Active duty service members and/or veterans with only tinnitus/no PTSD.
Healthy Controls	resting-state functional MRI	Active duty service members and/or veterans with no PTSD and no tinnitus.
Healthy Controls	Quick Speech in Noise Test	Active duty service members and/or veterans with no PTSD and no tinnitus.
Tinnitus and PTSD (T+P)	Quick Speech in Noise Test	Active duty service members and/or veterans with PTSD and tinnitus.
Tinnitus Only (TO)	Tympanometry	Active duty service members and/or veterans with only tinnitus/no PTSD.
PTSD Only (PO)	Distortion-Product Otoacoustic Emissions (DPOAE)	Active duty service members and/or veterans with only PTSD/no tinnitus.
Healthy Controls	Pure tone air and bone-conduction	Active duty service members and/or veterans with no PTSD and no tinnitus.
Healthy Controls	Distortion-Product Otoacoustic Emissions (DPOAE)	Active duty service members and/or veterans with no PTSD and no tinnitus.
Tinnitus Only (TO)	Loudness Discomfort	Active duty service members and/or veterans with only tinnitus/no PTSD.
PTSD Only (PO)	Otoscopy	Active duty service members and/or veterans with only PTSD/no tinnitus.
Healthy Controls	Tympanometry	Active duty service members and/or veterans with no PTSD and no tinnitus.
Healthy Controls	Otoscopy	Active duty service members and/or veterans with no PTSD and no tinnitus.
PTSD Only (PO)	resting-state functional MRI	Active duty service members and/or veterans with only PTSD/no tinnitus.
PTSD Only (PO)	Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)	Active duty service members and/or veterans with only PTSD/no tinnitus.
PTSD Only (PO)	Pure tone air and bone-conduction	Active duty service members and/or veterans with only PTSD/no tinnitus.
PTSD Only (PO)	Speech testing	Active duty service members and/or veterans with only PTSD/no tinnitus.
PTSD Only (PO)	Loudness Discomfort	Active duty service members and/or veterans with only PTSD/no tinnitus.
PTSD Only (PO)	Quick Speech in Noise Test	Active duty service members and/or veterans with only PTSD/no tinnitus.

Primary Outcome Measures

Name	Time	Method
Resting-State Functional MRI	30 minutes of acquired data	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.

Trial Locations

Locations (1)

UT Health San Antonio; 🇺🇸 San Antonio, Texas, United States