Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

Not Applicable

Completed

• Conditions: Tinnitus

• Registration Number: NCT02669069
• Lead Sponsor: Neuromod Devices Ltd.

Brief Summary

This is a three 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. 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.

Study Timeline

• Study First Submitted: 2016-01-27
• Study First Submitted QC: 2016-01-28
• Study First Posted: 2016-01-29
• Study Start: 2016-06-27
• Primary Completion: 2017-07-31
• Study Completion: 2019-01-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tinnitus Functional Index	Between baseline and 12 weeks
Tinnitus Handicap Inventory	Between baseline and 12 weeks

Trial Locations

Locations (2)

University Hospital Regensburg; 🇩🇪 Regensburg, Germany

St. James's Wellness Trust Clinical Research Facility; 🇮🇪 Dublin, Ireland