Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
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ClinicalTrials.gov Identifier: NCT02669069 |
Recruitment Status :
Completed
First Posted : January 29, 2016
Last Update Posted : December 24, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tinnitus | Device: PS1 Device: PS2 Device: PS3 | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 326 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Device Feasibility |
Official Title: | Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A) |
Actual Study Start Date : | June 27, 2016 |
Actual Primary Completion Date : | July 31, 2017 |
Actual Study Completion Date : | January 30, 2019 |
Arm | Intervention/treatment |
---|---|
Active Comparator: PS1 |
Device: PS1
Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are synchronous with the tones. |
Active Comparator: PS2 |
Device: PS2
Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones. |
Active Comparator: PS3 |
Device: PS3
Participants in this arm shall be given an audio stimulus which comprises of a sequence of single-frequency tones mixed with a broadband noise with the frequency characteristics of both chosen outside the region of any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones. |
- Tinnitus Functional Index [ Time Frame: Between baseline and 12 weeks ]
- Tinnitus Handicap Inventory [ Time Frame: Between baseline and 12 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 to 70 years of age
- The ability to read and understand English/German
- Willing and able to provide informed consent
- Willing to commit to the full duration of the study
- Have been experiencing tinnitus 3 months to 5 years
- Experiencing subjective tinnitus
- Baseline Tinnitus Handicap Inventory (THI) score of 28 to 76 points
- Baseline Minimum Masking Level (MML) of 20 to 80 dBHL
- Maximum AC pure-tone audiometry hearing loss of 80 dB HL at any test frequency in the range of 2 to 8 kHz or of 40 dB HL in the range of 250 to 1000 Hz either unilaterally or bi-laterally
Exclusion Criteria:
- If participant has been 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 MML assessment
- Meniere's disease
- Significantly severe Loudness Discomfort Level (LDL), <30 dB SL
- Depression or neuro-psychological condition, previously diagnosed or identified from the State-Trait Anxiety Inventory (STAI) scores 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 conditions 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
- Pacemakers or other electro-active implanted devices
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669069
Germany | |
University Hospital Regensburg | |
Regensburg, Germany | |
Ireland | |
St. James's Wellness Trust Clinical Research Facility | |
Dublin, Ireland |
Principal Investigator: | Mr. Brendan Conlon | St. James's Hospital, Dublin | |
Principal Investigator: | Prof. Dr. med. Berthold Langguth | University of Regensburg |
Responsible Party: | Neuromod Devices Ltd. |
ClinicalTrials.gov Identifier: | NCT02669069 |
Other Study ID Numbers: |
Neuromoddevices TENT-A1 (Stage A1) ( Other Identifier: Neuromod Devices Ltd. ) |
First Posted: | January 29, 2016 Key Record Dates |
Last Update Posted: | December 24, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bi-modal neuromodulation |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |