Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2 (TENT-A2)

Neuromod Devices

Status: Completed

Conditions: Tinnitus

Treatments: Device: PS1-PS4; Device: PS6-PS10; Device: PS7-PS4; Device: PS9-PS6

Study type: Interventional

Funder types: Industry

Identifiers

NCT03530306

Neuromoddevices TENT-A2

Details and patient eligibility

About

This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Full 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.

Enrollment: 191 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• 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

Exclusion criteria

• 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)
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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191 participants in 4 patient groups

PS1-PS4

Active Comparator group

Treatment:

Device: PS1-PS4

PS6-PS10

Active Comparator group

Treatment:

Device: PS6-PS10

PS7-PS4

Active Comparator group

Treatment:

Device: PS7-PS4

PS9-PS6

Active Comparator group

Treatment:

Device: PS9-PS6