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

NCT01988688 | Completed Phase 1 DMC

• 1 other identifier: DBS Tinnitus
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Tinnitus

Keywords

deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Tinnitus Functional Index (TFI) score change

  Between Baseline and Period I, Week 24

  Up to 18 months

Study Arms (1)

Bilateral DBS placement in area LC

EXPERIMENTAL

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)

Interventions

Deep Brain Stimulation (DBS) DEVICE

Deep Brain Stimulation (DBS) bilaterally in area LC.

Bilateral DBS placement in area LC

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paul Larson: lead

Study Sites (1)

San Francisco Veterans' Administration Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (2)

• Cheung SW, Racine CA, Henderson-Sabes J, Demopoulos C, Molinaro AM, Heath S, Nagarajan SS, Bourne AL, Rietcheck JE, Wang SS, Larson PS. Phase I trial of caudate deep brain stimulation for treatment-resistant tinnitus. J Neurosurg. 2019 Sep 24;133(4):992-1001. doi: 10.3171/2019.4.JNS19347. Print 2020 Oct 1.

  PMID: 31553940 DERIVED

• Perez PL, Wang SS, Heath S, Henderson-Sabes J, Mizuiri D, Hinkley LB, Nagarajan SS, Larson PS, Cheung SW. Human caudate nucleus subdivisions in tinnitus modulation. J Neurosurg. 2019 Feb 8;132(3):705-711. doi: 10.3171/2018.10.JNS181659. Print 2020 Mar 1.

  PMID: 30738400 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Paul Larson, MD

  San Francisco VA Medical Center

  PRINCIPAL INVESTIGATOR

• Steven Cheung, MD

  San Francisco VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 20, 2013
• Study Start: January 1, 2014
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)