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TinnitusPhase 1NCT01988688

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

A Phase 1 study testing Deep Brain Stimulation (DBS) in people with Tinnitus, run by Paul Larson at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 22 to 75 years
Conditions the study is for
Tinnitus
What is being tested?
Deep Brain Stimulation (DBS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jan 2014to Mar 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • San Francisco Veterans' Administration Medical Center

    San Francisco, California, 94121

Other trials in United States

About this study

Official title: 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).

Read the 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.

Conditions
Tinnitus
Being tested
Deep Brain Stimulation (DBS)
Keywords
deep brain stimulation
Medical subject headings
Tinnitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep Brain Stimulation (DBS)Device

    Deep Brain Stimulation (DBS) bilaterally in area LC.

Study groups in NCT01988688
Study groupRoleWhat they receive
Bilateral DBS placement in area LCExperimentalBilateral 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
Receives: Device: Deep Brain Stimulation (DBS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tinnitus Functional Index (TFI) score change

    Between Baseline and Period I, Week 24

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2013 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2019
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01988688
Sponsor's protocol ID
DBS Tinnitus
Status last verified
Apr 2019
First submitted
13 Nov 2013
Last updated
18 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31553940

  • 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.

    PubMed 30738400

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Deep Brain Stimulation (DBS) in people with Tinnitus, run by Paul Larson at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tinnitus Functional Index (TFI) score change (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01988688, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.

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