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Somatosensory Based Treatments for Tinnitus

Primary Purpose

Tinnitus

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
P-Stim
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age range: above age 18

Exclusion Criteria:

  • people with a bleeding disorder,
  • and those on coumadin will be excluded

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    P-Stim device

    Arm Description

    Receiving the device that is activated

    Outcomes

    Primary Outcome Measures

    Quieter tinnitus

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2010
    Last Updated
    December 29, 2016
    Sponsor
    Massachusetts Eye and Ear Infirmary
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01066273
    Brief Title
    Somatosensory Based Treatments for Tinnitus
    Official Title
    Somatosensory Based Treatments for Tinnitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2008
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Principal Investigator no longer at institution
    Study Start Date
    December 2008 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Massachusetts Eye and Ear Infirmary

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Studies have established that the somatosensory system of the upper cervical region and head can be intimately involved in tinnitus. Tinnitus can arise directly from a disorder of the head and upper neck via the somatosensory system. Our clinical experience and review of reports of various types of treatments support the hypothesis that treatment modalities involving the somatosensory system can benefit individuals whose tinnitus is likely on a somatosensory basis, namely people with symmetric hearing thresholds but asymmetric widely fluctuating tinnitus. However these previous studies did not (a) limit their treatment population to only people with tinnitus on a somatosensory basis and (b) did not assess their results by considering this tinnitus subpopulation separately from the entire group of tinnitus subjects they treated. Hence, the purpose of this study is to re-assess these treatments by targeting people whose audiograms can not account for their tinnitus, such as individuals with symmetric hearing thresholds but asymmetric widely fluctuating tinnitus
    Detailed Description
    Until recently our attempts over the years at treatment of patients with such types of tinnitus has met with little or no success. These treatments have included cervical physical therapy and dental treatments for bruxism. A few with such tinnitus responded have had some benefit from acupuncture applied to their periauricular region. A small formal trial with a few patients did not provide any relief. However a literature review (Levine et al., 2007) found a consistent line of evidence for a tinnitus subgroup responsive to somatosensory based treatment modalities, including electrical stimulation in the periauricular region, and acupuncture. Furthermore an electrical stimulation device of the auricle P-Stim was found to be more effective than standard acupuncture for a variety of conditions, including chronic cervical and low back pain. For this convergence of reasons we have initiated an open trial with P-Stim over the past 11 months. In a sense we have used it in an "off-label" capacity; just as many medications have been found to be useful for conditions for which the medications were not developed (see Levine 2006). The P-Stim is a battery-powered, transcutaneous electrical stimulator that delivers 1 per second bipolar 1 millisecond pulses to three points on the auricle. The device connects via three fine insulated stainless steel wires to three needles (each 0.4 mm diameter, 2 mm long) that have been applied to three different points on the auricle. The device is powered by three zinc air batteries, each with a voltage of 1.4 V. The device is on for 180 minutes, then off for 180 minutes, for a maximum period of up to 96 hours. The battery and electronics are contained in a 6 mm by 2.5 mm pack that has one adhesive surface which is applied to the skin behind the ear. The adhesive is conductive and acts as the return for the device. The battery pack is secured with tape. We have met with some success using P-Stim for what appear to be two tinnitus subgroups: somatic pulsatile tinnitus syndrome (Levine et al., 2008) and patients with non-pulsatile unilateral fluctuating tinnitus associated with deep ear pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    P-Stim device
    Arm Type
    Experimental
    Arm Description
    Receiving the device that is activated
    Intervention Type
    Device
    Intervention Name(s)
    P-Stim
    Intervention Description
    The P-Stim is a battery-powered, transcutaneous electrical stimulator that delivers 1 per second bipolar 1 millisecond pulses to three points on the auricle. The device connects via three fine insulated stainless steel wires to three needles (each 0.4 mm diameter, 2 mm long) that have been applied to three different points on the auricle. The device is powered by three zinc air batteries, each with a voltage of 1.4 V. The device is on for 180 minutes, then off for 180 minutes, for a maximum period of up to 96 hours. The battery and electronics are contained in a 6 mm by 2.5 mm pack that has one adhesive surface which is applied to the skin behind the ear. The adhesive is conductive and acts as the return for the device. The battery pack is secured with tape.
    Primary Outcome Measure Information:
    Title
    Quieter tinnitus
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age range: above age 18 Exclusion Criteria: people with a bleeding disorder, and those on coumadin will be excluded

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Somatosensory Based Treatments for Tinnitus

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