Clinical trial NCT02669069: Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
Official title: Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Bi-modal neuromodulation
Lead sponsor: Neuromod Devices Ltd.
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Regensburg
First posted: 2016-01-29
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tinnitus Functional Index
timeFrame: Between baseline and 12 weeks
measure: Tinnitus Handicap Inventory
timeFrame: Between baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital Regensburg
city: Dublin
country: Ireland
facility: St. James's Wellness Trust Clinical Research Facility
Study officials:
affiliation: St. James's Hospital, Ireland
name: Mr. Brendan Conlon
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Regensburg
name: Prof. Dr. med. Berthold Langguth
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Arcy S, Hamilton C, Hughes S, Hall DA, Vanneste S, Langguth B, Conlon B. Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping. BMJ Open. 2017 Oct 25;7(10):e018465. doi: 10.1136/bmjopen-2017-018465.
citation: Conlon B, Langguth B, Hamilton C, Hughes S, Meade E, Connor CO, Schecklmann M, Hall DA, Vanneste S, Leong SL, Subramaniam T, D'Arcy S, Lim HH. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. Sci Transl Med. 2020 Oct 7;12(564):eabb2830. doi: 10.1126/scitranslmed.abb2830.