Trial Outcomes & Findings for Neurobiological Similarities of Tinnitus and PTSD (NCT NCT05981391)

Last Updated: 2025-07-08

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

64 participants

Primary outcome timeframe

30 minutes of acquired data

Results posted on

2025-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Tinnitus and PTSD (T+P) Active duty service members and/or veterans with PTSD and tinnitus.	Tinnitus Only (TO) Active duty service members and/or veterans with only tinnitus/no PTSD.	PTSD Only (PO) Active duty service members and/or veterans with only PTSD/no tinnitus.	Healthy Controls Active duty service members and/or veterans with no PTSD and no tinnitus.
Overall Study STARTED	16	25	3	20
Overall Study COMPLETED	12	24	3	19
Overall Study NOT COMPLETED	4	1	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neurobiological Similarities of Tinnitus and PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tinnitus and PTSD (T+P) n=16 Participants Active duty service members and/or veterans with PTSD and tinnitus.	Tinnitus Only (TO) n=25 Participants Active duty service members and/or veterans with only tinnitus/no PTSD.	PTSD Only (PO) n=3 Participants Active duty service members and/or veterans with only PTSD/no tinnitus.	Healthy Controls n=20 Participants Active duty service members and/or veterans with no PTSD and no tinnitus.	Total n=64 Participants Total of all reporting groups
Age, Continuous	48.98 years STANDARD_DEVIATION 15.28 • n=5 Participants	49.39 years STANDARD_DEVIATION 15.50 • n=7 Participants	47.69 years STANDARD_DEVIATION 14.87 • n=5 Participants	45.37 years STANDARD_DEVIATION 16.00 • n=4 Participants	48.89 years STANDARD_DEVIATION 15.17 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	19 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	17 Participants n=7 Participants	1 Participants n=5 Participants	13 Participants n=4 Participants	45 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	14 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	18 Participants n=7 Participants	1 Participants n=5 Participants	17 Participants n=4 Participants	49 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	21 Participants n=7 Participants	1 Participants n=5 Participants	14 Participants n=4 Participants	50 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment United States	16 participants n=5 Participants	25 participants n=7 Participants	3 participants n=5 Participants	20 participants n=4 Participants	64 participants n=21 Participants

PRIMARY outcome

Timeframe: 30 minutes of acquired data

Outcome measures

Outcome measures
Measure	Tinnitus and PTSD (T+P) n=12 Participants Active duty service members and/or veterans with PTSD and tinnitus.	Tinnitus Only (TO) n=24 Participants Active duty service members and/or veterans with only tinnitus/no PTSD.	PTSD Only (PO) n=3 Participants Active duty service members and/or veterans with only PTSD/no tinnitus.	Healthy Controls n=19 Participants Active duty service members and/or veterans with no PTSD and no tinnitus.
Resting-State Functional MRI Right Precuneus	0.55 Z-Score Standard Deviation 0.33	0.35 Z-Score Standard Deviation 0.24	0.29 Z-Score Standard Deviation 0.22	0.59 Z-Score Standard Deviation 0.28
Resting-State Functional MRI Left Cerebellum	0.46 Z-Score Standard Deviation 0.18	0.36 Z-Score Standard Deviation 0.20	0.47 Z-Score Standard Deviation 0.27	0.54 Z-Score Standard Deviation 0.28
Resting-State Functional MRI Left Superior Temporal Gyrus	1.80 Z-Score Standard Deviation 0.49	1.67 Z-Score Standard Deviation 0.44	1.68 Z-Score Standard Deviation 0.45	1.95 Z-Score Standard Deviation 0.38
Resting-State Functional MRI Left Cingulate Gyrus	1.54 Z-Score Standard Deviation 0.47	1.60 Z-Score Standard Deviation 0.49	1.49 Z-Score Standard Deviation 0.44	1.99 Z-Score Standard Deviation 0.38
Resting-State Functional MRI Right Lentiform Nucleus	1.03 Z-Score Standard Deviation 0.17	1.07 Z-Score Standard Deviation 0.19	0.97 Z-Score Standard Deviation 0.02	1.22 Z-Score Standard Deviation 0.23
Resting-State Functional MRI Right Middle Frontal Gyrus	0.39 Z-Score Standard Deviation 0.44	0.55 Z-Score Standard Deviation 0.32	0.37 Z-Score Standard Deviation 0.55	0.84 Z-Score Standard Deviation 0.29
Resting-State Functional MRI Left Claustrum	0.66 Z-Score Standard Deviation 0.20	0.73 Z-Score Standard Deviation 0.17	0.84 Z-Score Standard Deviation 0.15	0.82 Z-Score Standard Deviation 0.26
Resting-State Functional MRI Right Supramarginal Gyrus	0.53 Z-Score Standard Deviation 0.40	0.98 Z-Score Standard Deviation 0.52	1.16 Z-Score Standard Deviation 0.97	0.95 Z-Score Standard Deviation 0.49
Resting-State Functional MRI Left Insula	0.24 Z-Score Standard Deviation 0.17	0.43 Z-Score Standard Deviation 0.24	0.29 Z-Score Standard Deviation 0.11	0.40 Z-Score Standard Deviation 0.17
Resting-State Functional MRI Left Medial Frontal Gyrus	1.32 Z-Score Standard Deviation 0.33	0.85 Z-Score Standard Deviation 0.29	0.64 Z-Score Standard Deviation 0.08	0.96 Z-Score Standard Deviation 0.33
Resting-State Functional MRI Right Insula	2.32 Z-Score Standard Deviation 0.32	2.82 Z-Score Standard Deviation 0.59	0.64 Z-Score Standard Deviation 0.48	2.86 Z-Score Standard Deviation 0.79

Adverse Events

Tinnitus and PTSD (T+P)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Tinnitus Only (TO)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

PTSD Only (PO)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tinnitus and PTSD (T+P) n=12 participants at risk Active duty service members and/or veterans with PTSD and tinnitus.	Tinnitus Only (TO) n=25 participants at risk Active duty service members and/or veterans with only tinnitus/no PTSD.	PTSD Only (PO) n=3 participants at risk Active duty service members and/or veterans with only PTSD/no tinnitus.	Healthy Controls n=24 participants at risk Active duty service members and/or veterans without PTSD and without tinnitus.
Psychiatric disorders Increased PTSD symptoms after evaluation	8.3% 1/12 • Number of events 1 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/25 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	33.3% 1/3 • Number of events 1 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/24 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.
Musculoskeletal and connective tissue disorders pain from shoulder injury	0.00% 0/12 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	4.0% 1/25 • Number of events 1 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/3 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/24 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.
Psychiatric disorders increased trauma trigger	8.3% 1/12 • Number of events 1 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/25 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/3 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/24 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.
Ear and labyrinth disorders increased perceived loudness of tinnitus	8.3% 1/12 • Number of events 1 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/25 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/3 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/24 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.
Psychiatric disorders increased tinnitus loudness in both ears	8.3% 1/12 • Number of events 1 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/25 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/3 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/24 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.
Psychiatric disorders anxiety	0.00% 0/12 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/25 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	33.3% 1/3 • Number of events 1 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.	0.00% 0/24 • 2 months AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.

Additional Information

Dr. John Moring

The University of Texas Health Science Center at San Antonio

Phone: 210-562-6716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place