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Device

Bilateral DBS placement in area LC for Tinnitus

Phase 1
Waitlist Available
Led By Steven Cheung, MD
Research Sponsored by Paul Larson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women between the ages of 22 and 75 years. Subjective, unilateral or bilateral, non-pulsatile tinnitus of 1 year's duration or greater.
Tinnitus Functional Index (TFI) score greater than 50. Tinnitus unresponsive acoustical and behavioral therapies. Prospective subjects must have received at least one acoustical (masker, hearing aid, Neuromonics®) or behavioral therapy (cognitive behavioral, directive counseling, tinnitus retraining therapy) to be eligible for study enrollment, but partial response to conventional therapy does not exclude a prospective subject if the individual meets the TFI > 50 study participation threshold.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Study Summary

This study will test the safety and effectiveness of deep brain stimulation (DBS) for patients with a big or very big problem with tinnitus (a sensation of noise in the head).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tinnitus Functional Index (TFI) score change

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bilateral DBS placement in area LCExperimental Treatment1 Intervention
Bilateral DBS placement in area LC. Devices include Medtronic Activa DBS model 3387 and 3389; Medtronic DBS extension; Medtronic Activa PC or Activa RC neurostimulator; Medtronic Patient Programmer; Medtronic Test Stimulator; Medtronic N/Vision Clinician Programmer
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation (DBS)
2011
Completed Phase 3
~50

Find a Location

Who is running the clinical trial?

Paul LarsonLead Sponsor
Steven Cheung, MDPrincipal InvestigatorSan Francisco VA Medical Center
Paul Larson, MDPrincipal InvestigatorSan Francisco VA Medical Center

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?
Massachusetts
Georgia
New Jersey
How old are they?
18 - 65
What site did they apply to?
San Francisco Veterans' Administration Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Mar 2025