Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

Study Overview
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Brief Summary
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This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Detailed Description
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Participants with chronic tinnitus will be provided with a CE marked neuromodulation device. Devices will be programmed with one of 3 stimulation parameter settings. After 12 weeks of use, differences in tinnitus severity scores will be compared between the 3 arms and within the arms for patient subtype analysis.

Official Title
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Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

Conditions
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Tinnitus

Intervention / Treatment
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* Device: PS1
* Device: PS2
* Device: PS3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PS1<br> | Device: PS1<br>* 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.<br>|
| Active Comparator: PS2<br> | Device: PS2<br>* 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.<br>|
| Active Comparator: PS3<br> | Device: PS3<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Functional Index |  | Between baseline and 12 weeks | 
| Tinnitus Handicap Inventory |  | Between baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bi-modal neuromodulation