NCT03621735

Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

Completed NA Results posted Last updated 30 August 2023

What this trial tests

NA trial testing Burst-SCS/sham SCS in Tinnitus in 100 participants. Completed in 6 July 2022.

Timeline

1 November 2018

Primary endpoint
6 July 2022

6 July 2022

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	100
Start date	1 November 2018
Primary completion	6 July 2022
Estimated completion	6 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Burst-SCS/sham SCS
• Sham SCS/Burst-SCS

Conditions studied

• Tinnitus — all drugs for Tinnitus →

Sponsor

University of Michigan

Who can join

18 and older, any sex, with Tinnitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Objective Tinnitus Loudness Primary · Up to 24 weeks

Change in Tinnitus by the TinnTester software. Participants are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). These will be collected weekly during each treatment arm and washout. Absolute differences are averaged relative to baseline to determine loudness change. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active Fi

Group	Value	95% CI
Active First	-6.1	± 1.8
Active-First Washout	-9.5	± 2.1
Active-First Then Sham	-10.2	± 2.3
Active-First-Then-Sham Washout	-11.0	± 2.5
Sham First	-3.7	± 1.3
Sham-First Washout	-4.7	± 1.5
Sham-First Then Active	-5.8	± 2.3
Sham-First-Then-Active Washout	-4.9	± 2.4

Change in Tinnitus Functional Index (TFI) Primary · Up to 36 weeks

TFI is a clinical questionnaire that assesses tinnitus impact on a participant's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact. These will be collected weekly during each treatment arm and washout. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and PSM 36 weeks

Group	Value	95% CI
Active First	-12.0	± 2.3
Active-First Washout	-13.1	± 2.4
Active-First Then Sham	-16.8	± 2.4
Active-First-Then-Sham Washout	-15.9	± 2.0
Active-First Post-Study Monitoring (PSM) Period	-12.1	± 2.7
Sham First	-6.5	± 1.9
Sham-First Washout	-8.3	± 2.0
Sham-First Then Active	-13.8	± 2.7
Sham-First-Then-Active Washout	-13.4	± 2.8
Sham-First Post-Study Monitoring (PSM) Period	-15.3	± 2.6

Tinnitus Handicap Inventory (THI) Primary · Up to 24 weeks

A 25 item questionnaire which assesses subjective impacts of tinnitus related to quality of life on a 100 point numeric scale. Scores 17 points or higher are considered bothersome tinnitus. The higher scores reflecting greater self-perceived tinnitus handicap. These will be collected weekly during each treatment arm and washout. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First t

Group	Value	95% CI
Active First	-5.8	± 2.1
Active-First Washout	-6.4	± 1.9
Active-First Then Sham	-8.0	± 2.6
Active-First-Then-Sham Washout	-6.9	± 2.0
Sham First	-1.6	± 1.5
Sham-First Washout	-2.2	± 1.7
Sham-First Then Active	-5.3	± 2.8
Sham-First-Then-Active Washout	-4.6	± 2.7

Change in Tinnitus Bandwidth/Spectrum (TinnTester Interactive Software) Secondary · Up to 24 weeks

Participants are guided through a self-directed computerized assessment software that estimates how similar their tinnitus is to a set of select sounds rated on a 0 - 100 scale where 0 is not similar \& 100 is identical. Treatment will relate outcomes to tinnitus bandwidth by these measurements and determine whether the treatment alters bandwidth. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18,

Group	Value	95% CI
Active First	7.1	± 0.9
Active-First Washout	8.4	± 1.0
Active-First Then Sham	9.5	± 1.0
Active-First-Then-Sham Washout	10.3	± 1.2
Sham First	8.0	± 0.9
Sham-First Washout	8.5	± 1.0
Sham-First Then Active	10.3	± 1.4
Sham-First-Then-Active Washout	11.0	± 1.5

Changes in Minimum Masking Level (MML) Secondary · Up to 24 weeks

Determine if the MML for a high-pass 2kHz broadband noise is change in the active treatment arm. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the end of each arm phase group, in six week intervals. Thus Active First below is at 6 weeks after baseline, Washout is at 12 weeks, Active First then Sham at 18, and Active First then Sham Washout at 24 and the same pattern for the Sham First group. Values presented are all shown as change from baseline.

Group	Value	95% CI
Active First	-5.1	± 2.3
Active-First Washout	-1.1	± 2.3
Active-First Then Sham	-2.0	± 2.9
Active-First-Then-Sham Washout	0.2	± 2.0
Sham First	-2.7	± 1.6
Sham-First Washout	-1.6	± 1.5
Sham-First Then Active	0.0	± 2.1
Sham-First-Then-Active Washout	-0.1	± 3.3

Tinnitus Hearing Survey Secondary · Up to 24 weeks

This is a 10-question survey with a scale from 0 to 4 to determine if active treatment has an effect or interaction with perceived handicap due to hearing loss and sound level tolerance. Categories are comprised of tinnitus, hearing, and sound tolerance. An answer of 0 is no/not a problem, and an answer of 4 is yes/a very big problem. The range for the total score is 0 - 40 with lower numbers meaning fewer hearing problems and higher numbers meaning more tinnitus, or hearing or sound tolerance problems. For each of the two arms, Active Then Sham and Sham Then Active, data is presented at the e

Group	Value	95% CI
Active First	-0.7	± 0.4
Active-First Washout	-1.8	± 0.4
Active-First Then Sham	-0.9	± 0.5
Active-First-Then-Sham Washout	-1.4	± 0.6
Sham First	-0.2	± 0.4
Sham-First Washout	-0.6	± 0.5
Sham-First Then Active	-1.3	± 0.5
Sham-First-Then-Active Washout	-1.5	± 0.6

Adverse events — posted to ClinicalTrials.gov

Time frame: From screening until end of Post-Study Monitoring (PSM) period up to 36 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Post-Enrollment Through Baseline Measures, Pre-use

Serious: 0/99 (0%)

Deaths: 0/99

Active

Serious: 0/86 (0%)

Deaths: 0/86

Active-Washout Period

Serious: 0/80 (0%)

Deaths: 0/80

Sham

Serious: 0/89 (0%)

Deaths: 0/89

Sham-Washout Period

Serious: 0/82 (0%)

Deaths: 0/82

Post-Study Monitoring (PSM)

Serious: 0/76 (0%)

Deaths: 0/76

Other adverse events (3 terms — click to expand)

Reaction	System	Post-Enrollment Through Ba…	Active	Active-Washout Period	Sham	Sham-Washout Period	Post-Study Monitoring (PSM)
medical infections	Infections and infestations	—	—	—	—	—	—
ent - head	Ear and labyrinth disorders	—	—	—	—	—	—
worsened tinnitus	Nervous system disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT03621735 adverse events section.

Sponsor's own description

The goal of the study is to reduce tinnitus (ringing in the ear) loudness and improve the quality of life for those that are affected by tinnitus. This study will enroll subjects who have constant and bothersome tinnitus with no greater than a mild hearing loss up to 6 kHz, and no greater than a moderate hearing loss in the tinnitus frequencies. Subjects must also have the ability to alter the loudness or pitch of the ringing in their ears by performing a head, neck, face, or upper body movement. Subjects will be given both the treatment and sham arms (the study will randomly assign which arm is administered first) and will have a washout period of 6 weeks after each arm. The study will take approximately 36 weeks for subjects to complete and will enroll up to 300 individuals.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reversing Synchronized Brain Circuits Using Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts: A Randomized Clinical Trial.
   Jones GR, Martel DT, Riffle TL, Errickson J, et al · · 2023 · cited 10× · PMID 37266943 · DOI 10.1001/jamanetworkopen.2023.15914