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Behavioural Intervention

Active then Sham for Tinnitus

N/A
Waitlist Available
Led By Susan Shore, Ph.D.
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 weeks
Awards & highlights

Study Summary

This study is evaluating whether a treatment for tinnitus can reduce the loudness of the ringing in the ears.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Objective Tinnitus Loudness
Change in Tinnitus Functional Index (TFI)
Tinnitus Handicap Inventory (THI)
Secondary outcome measures
Change in Tinnitus Bandwidth/Spectrum (TinnTester Interactive Software)
Changes in Minimum Masking Level (MML)
Tinnitus Hearing Survey

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sham then ActiveExperimental Treatment1 Intervention
Active: Bimodal auditory-somatosensory stimulation Sham: Sham Bimodal auditory-somatosensory stimulation Subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation.
Group II: Active then ShamExperimental Treatment1 Intervention
Active: Bimodal auditory-somatosensory stimulation Sham: Sham Bimodal auditory-somatosensory stimulation Subjects receive both an active treatment and a sham treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sham SCS/Burst-SCS
2018
N/A
~100
Burst-SCS/sham SCS
2018
N/A
~100

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,049 Total Patients Enrolled
University of MichiganLead Sponsor
1,795 Previous Clinical Trials
6,373,836 Total Patients Enrolled
1 Trials studying Tinnitus
35 Patients Enrolled for Tinnitus
Susan Shore, Ph.D.Principal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
North Carolina
Other
Indiana
Michigan
How old are they?
65+
18 - 65
What site did they apply to?
The University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts
Susan E. Shore 2018. "Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03621735.
~16 spots leftby Apr 2025
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