Pilot Study of Deep Brain Stimulation (DBS) in Area LC for Chronic Tinnitus

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
Paul Larson, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01988688
First received: November 13, 2013
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Tinnitus
Device: Deep Brain Stimulation (DBS)
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 10
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)
Arms Assigned Interventions
Experimental: Bilateral DBS surgery with placement in area LC
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   22 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Montreal Cognitive Assessment (MoCA) ≥ 26. Subjects of child-bearing potential using an appropriate form of birth control acceptable to the research team and with a negative urine pregnancy test or has undergone sterilization procedure.

Capacity to give informed consent. English-speaking.

Exclusion Criteria:

Patients experiencing tinnitus related to untreated retrocochlear lesion, or other known anatomic/structural lesions of the ear or temporal bone.

Patients with hyperacusis or misophonia (hypersensitivity to loud noises). Hearing loss of moderately severe or greater severity in either ear. History of seizure disorder or currently under treatment for seizure disorder. Patients with cardiac pacemakers, intracardiac lines, implanted medication pumps, implanted electrodes in the brain, other intracranial metal objects with the exception of dental fillings, or any other contraindication for obtaining a MRI scan.

Patients with an acute or chronic unstable medical condition which, in the opinion of the PI, would require stabilization prior to or preclude DBS surgery.

Patients with any active ear disease that, in the opinion of the PI, needs to be further evaluated.

Patients with psychiatric symptoms that, in the opinion of the study team, are not adequately treated or would interfere with study activities.

Any psychiatric co-morbidity that may complicate the interpretation of study results.

Pregnancy. Currently breast-feeding. Patients with tinnitus related to Workman's Compensation claim or litigation-related event.

Patients taking any medication(s), in the opinion of the PI, that is (are) deemed to be etiologically related to the development of tinnitus.

Preoperative neurophychological evaluation that indicates either of the following:

Dementia - Using DSM-IV criteria of memory impairment and at least one of the following: aphasia, apraxia, agnosia or disturbances in executive functioning. The cognitive impairments must be severe enough to cause impairment in social and occupational functioning and must represent a decline from a previously higher level of functioning. The diagnosis of dementia will not be made if the cognitive deficits occur exclusively during the course of a delirium.

Cognitive impairment (z < -1.5) in multiple domains without dementia (i.e. patient is functionally intact), but in the opinion of the study team would not or could not comply with study requirements.

Beck Depression Inventory-II (BDI-II) > 29, indicating severe depression. Patients with a history of claustrophobia that would interfere with MRI or surgery.

Active alcohol and/or drug dependence or history of alcohol and/or ETOH dependence within the last year.

Any medical condition that, in the opinion of the investigators, confounds study results or places the subject at greater risk.

Unable to provide informed consent.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988688

Contacts
Contact: Sarah Wang, PhD 415-353-7885 sarah.wang@ucsf.edu

Locations
United States, California
San Francisco Veterans' Administration Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: Sarah Wang, PhD    415-353-7885    sarah.wang@ucsf.edu   
Principal Investigator: Paul S. Larson, MD         
Principal Investigator: Steven Cheung, MD         
Sponsors and Collaborators
Paul Larson
Investigators
Principal Investigator: Paul Larson, MD San Francisco VA Medical Center
Principal Investigator: Steven Cheung, MD San Francisco VA Medical Center
  More Information

No publications provided

Responsible Party: Paul Larson, Principal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01988688     History of Changes
Other Study ID Numbers: DBS Tinnitus
Study First Received: November 13, 2013
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
deep brain stimulation

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014