Suspended

Somatosensory Based Treatments for Tinnitus

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What is being tested

P-Stim

Device
Who is being recruted

Ear Diseases+6

+ Hearing Disorders

+ Nervous System Diseases

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2008
See protocol details

Summary

Principal SponsorMassachusetts Eye and Ear Infirmary
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2008

Actual date on which the first participant was enrolled.

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.

Official TitleSomatosensory Based Treatments for Tinnitus
NCT01066273
Principal SponsorMassachusetts Eye and Ear Infirmary
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesHearing DisordersNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsTinnitus

Criteria

1 inclusion criteria required to participate
Age range: above age 18

2 exclusion criteria prevent from participating
people with a bleeding disorder,

and those on coumadin will be excluded

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Receiving the device that is activated

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers