Pilot Study of Deep Brain Stimulation (DBS) in Area LC for Chronic Tinnitus
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Deep Brain Stimulation (DBS)in Area LC for Chronic Tinnitus|
- Tinnitus Functional Index (TFI) score change in Period I [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]in Period I, between Week 0 and Week 24.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
Experimental: Bilateral DBS placement in area LC
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
Device: Deep Brain Stimulation (DBS)
Deep Brain Stimulation (DBS) bilaterally in area LC.
This is a single institution, open-label, phase I clinical trial to estimate the treatment effect size and to assess preliminary safety and tolerability of DBS in the caudate nucleus (area LC) in adults with a big or very big problem (tinnitus functional index TFI>50) with chronic tinnitus. Up to 10 subjects will be implanted. The DBS stimulation parameters are patient-specific and will be allowed to vary over the course of the treatment periods, calibrated by the TFI. During Period I, stimulation will be continuous. During Period II, there will be three stimulation OFF/ON epochs, where the stimulation will be turned OFF and then turned back ON when the tinnitus loudness returns to a certain level (based on a change in the TFI score). During Period III, stimulation will be "on demand," i.e. controlled by the subject and determined by subject preference. An important goal is to determine whether tinnitus can be controlled through optimization of stimulation parameters.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988688
|Contact: Sarah Wang, PhDfirstname.lastname@example.org|
|United States, California|
|San Francisco Veterans' Administration Medical Center||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Sarah Wang, PhD 415-353-7885 email@example.com|
|Principal Investigator: Paul S. Larson, MD|
|Principal Investigator: Steven Cheung, MD|
|Principal Investigator:||Paul Larson, MD||San Francisco VA Medical Center|
|Principal Investigator:||Steven Cheung, MD||San Francisco VA Medical Center|