Severe TinnitusNCT01253616
Proof-of-Concept Study Assessing VNS Paired With Tones for Tinnitus
A study testing vagus nerve stimulation (VNS) in people with Severe Tinnitus, run by MicroTransponder Inc. at 1 site in Belgium.
Trial summary
This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus. The study is expected to give preliminary efficacy and safety information. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Tinnitus
- What is being tested?
- vagus nerve stimulation (VNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2010to Jun 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age
- Diagnosed with subjective tinnitus due to hearing loss with at least some tonal quality of the tinnitus.
- Diagnosis of tinnitus for at least one year
- Tinnitus severity of 18 or greater on TRQ cross checked with TQ severity of Grade 3 or worse
Who cannot join
- Acute or intermittent tinnitus
- Severe hearing loss
- History of significant ear disease such as Meniere's disease, ear tumors, or evidence of active middle ear disease.
- Any other implanted device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus. The study is expected to give preliminary efficacy and safety information.
- Conditions
- Severe Tinnitus
- Being tested
- vagus nerve stimulation (VNS)
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vagus nerve stimulation (VNS)Device
Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).
| Study group | Role | What they receive |
|---|---|---|
| VNS plus tones | Experimental | Not described Receives: Device: vagus nerve stimulation (VNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometric measurements
Measured: weekly through one month
Secondary outcomes (2)
tinnitus questionaires
Measured: weekly through one month
adverse events
Measured: as they occur
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroTransponder Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253616
- Sponsor's protocol ID
- MT-T-01
- Status last verified
- Feb 2017
- First submitted
- 2 Dec 2010
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
De Ridder D, Vanneste S, Engineer ND, Kilgard MP. Safety and efficacy of vagus nerve stimulation paired with tones for the treatment of tinnitus: a case series. Neuromodulation. 2014 Feb;17(2):170-9. doi: 10.1111/ner.12127. Epub 2013 Nov 20.
PubMed 24255953De Ridder D, Kilgard M, Engineer N, Vanneste S. Placebo-controlled vagus nerve stimulation paired with tones in a patient with refractory tinnitus: a case report. Otol Neurotol. 2015 Apr;36(4):575-80. doi: 10.1097/MAO.0000000000000704.
PubMed 25689839
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Pilot Study Assessing Vagus Nerve Stimulation (VNS) Paired With Tones for Tinnitus
- ClinicalTrials.gov ID
- NCT01253616
- Acronym / sponsor ID
- MT-T-01
- Conditions
- Severe Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MicroTransponder Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Dec 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.
This is a proof-of-concept study designed to provide feasibility information on the clinical use of vagus nerve stimulation (VNS) paired with tones for the treatment of severe tinnitus. The study is expected to give preliminary efficacy and safety information.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VNS plus tones | Experimental | Device: vagus nerve stimulation (VNS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 65 years of age
- Diagnosed with subjective tinnitus due to hearing loss with at least some tonal quality of the tinnitus.
- Diagnosis of tinnitus for at least one year
- Tinnitus severity of 18 or greater on TRQ cross checked with TQ severity of Grade 3 or worse
Key exclusion criteria (4 listed)
- Acute or intermittent tinnitus
- Severe hearing loss
- History of significant ear disease such as Meniere's disease, ear tumors, or evidence of active middle ear disease.
- Any other implanted device
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 |
|---|---|---|
| vagus nerve stimulation (VNS)Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period). | Device | VNS plus tones |
Primary outcome
Audiometric measurements
Time frame: weekly through one month
2 secondary outcomes
tinnitus questionaires
Time frame: weekly through one month
adverse events
Time frame: as they occur
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Results publication: PubMed 24255953De Ridder D, Vanneste S, Engineer ND, Kilgard MP. Safety and efficacy of vagus nerve stimulation paired with tones for the treatment of tinnitus: a case series. Neuromodulation. 2014 Feb;17(2):170-9. doi: 10.1111/ner.12127. Epub 2013 Nov 20.
- Results publication: PubMed 25689839De Ridder D, Kilgard M, Engineer N, Vanneste S. Placebo-controlled vagus nerve stimulation paired with tones in a patient with refractory tinnitus: a case report. Otol Neurotol. 2015 Apr;36(4):575-80. doi: 10.1097/MAO.0000000000000704.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vagus nerve stimulation (VNS) in people with Severe Tinnitus, run by MicroTransponder Inc. at 1 site in Belgium.
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 4 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 17 Feb 2017. 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 Belgium. 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.
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?
Audiometric measurements (time frame: weekly through one month). 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 NCT01253616, 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 17 Feb 2017.