Clinical trial NCT03530306: Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2
Official title: Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2 (TENT-A2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Lead sponsor: Neuromod Devices Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-21
Enrollment: 191
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 four 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: Between-arm and within-arm changes in THI after 6 weeks of treatment
Secondary outcomes:
Other outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: Between-arm and within-arm changes in THI after 12 weeks of treatment
Locations:
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
References:
citation: Conlon B, Hamilton C, Hughes S, Meade E, Hall DA, Vanneste S, Langguth B, Lim HH. Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters. JMIR Res Protoc. 2019 Sep 27;8(9):e13176. doi: 10.2196/13176.
citation: Conlon B, Hamilton C, Meade E, Leong SL, O Connor C, Langguth B, Vanneste S, Hall DA, Hughes S, Lim HH. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Sci Rep. 2022 Jun 30;12(1):10845. doi: 10.1038/s41598-022-13875-x.