TinnitusNCT01066273
Somatosensory Based Treatments for Tinnitus
A study testing P-Stim in people with Tinnitus, run by Massachusetts Eye and Ear Infirmary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- P-Stim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Dec 2016
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: above age 18
Who cannot join
- people with a bleeding disorder,
- and those on coumadin will be excluded
About this study
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
Read the 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.
- Conditions
- Tinnitus
- Being tested
- P-Stim
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-StimDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| P-Stim device | Experimental | Receiving the device that is activated Receives: Device: P-Stim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quieter tinnitus
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startDec 2008
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Principal Investigator no longer at institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066273
- Sponsor's protocol ID
- 08-12-056
- Status last verified
- Dec 2008
- First submitted
- 8 Feb 2010
- Last updated
- 30 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatosensory Based Treatments for Tinnitus
- ClinicalTrials.gov ID
- NCT01066273
- Acronym / sponsor ID
- 08-12-056
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator no longer at institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P-Stim device | Experimental | Device: P-StimReceiving the device that is activated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age range: above age 18
Key exclusion criteria (2 listed)
- people with a bleeding disorder,
- and those on coumadin will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-StimThe 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. | Device | P-Stim device |
Primary outcome
Quieter tinnitus
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing P-Stim in people with Tinnitus, run by Massachusetts Eye and Ear Infirmary.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quieter tinnitus (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2016.