Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

Neuromod Devices

Status

Completed

Conditions

Tinnitus

Treatments

Device: PS3

Device: PS2

Device: PS1

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02669069

Neuromoddevices

TENT-A1 (Stage A1) (Other Identifier)

Details and patient eligibility

About

This is a three 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. 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.

Enrollment

326 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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