TinnitusTENT-A2NCT03530306
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2
A study testing PS1-PS4, PS6-PS10 and PS7-PS4 in people with Tinnitus, run by Neuromod Devices Ltd. at 1 site in Ireland.
Trial summary
This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- PS1-PS4, PS6-PS10 and PS7-PS4
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 1 siteIreland
- Study dates
- 20 Mar 2018to 18 Jul 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years of age
- Ability to read and understand English
- Willing and able to provide informed consent
- Willing to commit to the full duration of the study
- Baseline Tinnitus Handicap Inventory (THI) score of >= 38 points
- Subjective tinnitus of 3 months to 10 years
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- Maximum AC pure-tone audiometry hearing loss of 80 dB HL in any test frequency in the set {2,3,4,6,8}kHz or 40 dB HL in the set {250,500,1000}Hz either unilaterally or bilaterally
- Baseline Minimum Masking Level (MML) of 20 to 80 dB HL
- Tonal tinnitus
Who cannot join
- Diagnosed with objective tinnitus
- Commenced usage of hearing aid within the last 90 days
- Cases where pulsatility is the dominant feature of tinnitus
- Patients whose tinnitus cannot be masked during Minimum Masking Level (MML) assessment
- Meniere's disease
- Significantly severe Loudness Discomfort Level (LDL, less than 30 dB SL)
Show all 21Show fewer
- Depression or neuro-psychological condition, previously diagnosed or identified from the State-Trait Anxiety Inventory (STAI) with score greater than 120
- Diagnosed with somatic tinnitus resulting from head or neck injury
- Temporomandibular Joint Disorder (TMJ)
- Current or previous involvement in medico-legal cases
- Pregnancy
- Oral piercings
- Neurological condition that may lead to loss of consciousness (e.g. epilepsy) or is considered to be the dominant feature of the tinnitus, as assessed by audiologist or ENT consultant
- Severe cognitive impairment based on Mini Mental State Examination (MMSE, less than 20)
- Patient with a pacemaker or other electro-active implanted device
- Have used Neuromod Devices products in the past
- Participants currently prescribed drugs for a central nervous system pathology, i.e. epilepsy, Multiple Sclerosis (MS), Parkinson's, bi-polar disorder
- The site Principal Investigator does not deem the candidate to be suitable for the study for other reasons not listed above
- Self-reporting episodes of auditory hallucinations
- Abnormal Otoscopy as assessed by the Audiologist, including active Otitis Media, perforation and hearing loss that is identified as completely conductive
- Abnormal Tympanometry as assessed by the Audiologist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2 (TENT-A2)
This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.
Read the detailed description
Participants with chronic tinnitus will be provided with a CE marked neuromodulation device. Participants are randomized to one of four different treatment arms. The treatment period is intended for 12 weeks of use. Based on the clinical investigation plan, participants are informed that their stimulation settings can change between the first and second halves of the treatment period and that the differences may be perceptually noticeable. Differences in tinnitus severity scores will be compared between and within treatment arms.
- Conditions
- Tinnitus
- Being tested
- PS1-PS4, PS6-PS10, PS7-PS4, PS9-PS6
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PS1-PS4Device
Participants in this arm shall be given PS1 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
PS6-PS10Device
Participants in this arm shall be given PS6 during the first half of treatment and PS10 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
PS7-PS4Device
Participants in this arm shall be given PS7 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
PS9-PS6Device
Participants in this arm shall be given PS9 during the first half of treatment and PS6 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
| Study group | Role | What they receive |
|---|---|---|
| PS1-PS4 | Active comparator | Not described Receives: Device: PS1-PS4 |
| PS6-PS10 | Active comparator | Not described Receives: Device: PS6-PS10 |
| PS7-PS4 | Active comparator | Not described Receives: Device: PS7-PS4 |
| PS9-PS6 | Active comparator | Not described Receives: Device: PS9-PS6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Handicap Inventory (THI)
Measured: Between-arm and within-arm changes in THI after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start20 Mar 2018
- Primary completion2 Oct 2018
- Study completion18 Jul 2019
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromod Devices Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mr. Brendan Conlon, Principal investigator, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530306
- Sponsor's protocol ID
- Neuromoddevices TENT-A2
- Acronym
- TENT-A2
- Status last verified
- Dec 2024
- First submitted
- 8 May 2018
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Conlon B, Hamilton C, Hughes S, Meade E, Hall DA, Vanneste S, Langguth B, Lim HH. Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters. JMIR Res Protoc. 2019 Sep 27;8(9):e13176. doi: 10.2196/13176.
PubMed 31573942Conlon B, Hamilton C, Meade E, Leong SL, O Connor C, Langguth B, Vanneste S, Hall DA, Hughes S, Lim HH. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Sci Rep. 2022 Jun 30;12(1):10845. doi: 10.1038/s41598-022-13875-x.
PubMed 35773272
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2 (TENT-A2)
- ClinicalTrials.gov ID
- NCT03530306
- Acronym / sponsor ID
- TENT-A2 / Neuromoddevices TENT-A2
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Neuromod Devices Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 2 Oct 2018 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 21 May 2018 (actual)
- 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 four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.
Detailed description
Participants with chronic tinnitus will be provided with a CE marked neuromodulation device. Participants are randomized to one of four different treatment arms. The treatment period is intended for 12 weeks of use. Based on the clinical investigation plan, participants are informed that their stimulation settings can change between the first and second halves of the treatment period and that the differences may be perceptually noticeable. Differences in tinnitus severity scores will be compared between and within treatment arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PS1-PS4 | Active comparator | Device: PS1-PS4 |
| PS6-PS10 | Active comparator | Device: PS6-PS10 |
| PS7-PS4 | Active comparator | Device: PS7-PS4 |
| PS9-PS6 | Active comparator | Device: PS9-PS6 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 70 years of age
- Ability to read and understand English
- Willing and able to provide informed consent
- Willing to commit to the full duration of the study
- Baseline Tinnitus Handicap Inventory (THI) score of >= 38 points
Key exclusion criteria (21 listed)
- Diagnosed with objective tinnitus
- Commenced usage of hearing aid within the last 90 days
- Cases where pulsatility is the dominant feature of tinnitus
- Patients whose tinnitus cannot be masked during Minimum Masking Level (MML) assessment
- Meniere's disease
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 |
|---|---|---|
| PS1-PS4Participants in this arm shall be given PS1 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation. | Device | PS1-PS4 |
| PS6-PS10Participants in this arm shall be given PS6 during the first half of treatment and PS10 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation. | Device | PS6-PS10 |
| PS7-PS4Participants in this arm shall be given PS7 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation. | Device | PS7-PS4 |
| PS9-PS6Participants in this arm shall be given PS9 during the first half of treatment and PS6 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation. | Device | PS9-PS6 |
Primary outcome
Tinnitus Handicap Inventory (THI)
Time frame: Between-arm and within-arm changes in THI after 6 weeks of treatment
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 20 Dec 2024.
- Background: PubMed 31573942Conlon B, Hamilton C, Hughes S, Meade E, Hall DA, Vanneste S, Langguth B, Lim HH. Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters. JMIR Res Protoc. 2019 Sep 27;8(9):e13176. doi: 10.2196/13176.
- Results publication: PubMed 35773272Conlon B, Hamilton C, Meade E, Leong SL, O Connor C, Langguth B, Vanneste S, Hall DA, Hughes S, Lim HH. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Sci Rep. 2022 Jun 30;12(1):10845. doi: 10.1038/s41598-022-13875-x.
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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.
Mr. Brendan Conlon principal investigator
St. James's Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PS1-PS4, PS6-PS10 and PS7-PS4 in people with Tinnitus, run by Neuromod Devices Ltd. at 1 site in Ireland.
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 9 inclusion and 21 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 20 Dec 2024. 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 Ireland. 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?
Tinnitus Handicap Inventory (THI) (time frame: Between-arm and within-arm changes in THI after 6 weeks of treatment). 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 NCT03530306, 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 20 Dec 2024.