Trial Outcomes & Findings for Resting-State Neural Connectivity in Patients With Subjective Tinnitus Without Bother (NCT NCT01049828)

Results Overview

Perform Functional connectivity MRI on participants with non-bothersome tinnitus. By undergoing a functional MRI, we are able to delineate the various networks involved with tinnitus including the default mode, attention, auditory, visual, somatosensory, and cognitive networks. The functional connectivity differences are measured by changes in blood oxygen level changes.

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

8 months for complete analysis on all participants

Results posted on

2024-07-25

Participant Flow

Those with subjective, idiopathic tinnitus were recruited from WU audiology and otolaryngology clinics.

1 participant was excluded due to claustrophobia from the MRI and another participant withdrew midway through the neurocognitive evaluation due to frustration.

Participant milestones

Participant milestones
Measure	Non-Bothered Tinnitus Group Participants who answer no bother or slight bother on a global tinnitus bothersome score. Tinnitus Handicap Index \<30.
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Non-Bothered Tinnitus Group Participants who answer no bother or slight bother on a global tinnitus bothersome score. Tinnitus Handicap Index \<30.
Overall Study Claustrophibia and Frustration	2

Baseline Characteristics

Resting-State Neural Connectivity in Patients With Subjective Tinnitus Without Bother

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Non-Bothered Tinnitus Group n=20 Participants Participants who answer no bother or slight bother on a global tinnitus bothersome score. Tinnitus Handicap Index \<30.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 months for complete analysis on all participants

Population: Perform Functional Connectivity MRI on Participants With Non-bothersome Tinnitus. Non-Bothered Tinnitus Group includes participants who answer 'no bother' or 'slight bother' on a global tinnitus bothersome scale and less than 30 on the Tinnitus Handicap Index.

Perform Functional connectivity MRI on participants with non-bothersome tinnitus. By undergoing a functional MRI, we are able to delineate the various networks involved with tinnitus including the default mode, attention, auditory, visual, somatosensory, and cognitive networks. The functional connectivity differences are measured by changes in blood oxygen level changes.

Outcome measures

Outcome measures
Measure	Non-Bothered Tinnitus Group n=18 Participants Perform Functional Connectivity MRI on Participants With Non-bothersome Tinnitus. Participants who answer no bother or slight bother on a global tinnitus bothersome score. Tinnitus Handicap Index \<30.
Number of Participants With Changes in Blood Oxygen Level as Measured by Functional Connectivity MRI	18 participants

Adverse Events

Non-Bothered Tinnitus Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andre Wineland

Washington University in St. Louis

Phone: 314-362-5296

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place