Tinnitus Clinical Trial
— TENT-A2Official title:
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2 (TENT-A2)
Verified date | September 2022 |
Source | Neuromod Devices Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.
Status | Completed |
Enrollment | 191 |
Est. completion date | July 18, 2019 |
Est. primary completion date | October 2, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ireland | St. James's Wellness Trust Clinical Research Facility | Dublin |
Lead Sponsor | Collaborator |
---|---|
Neuromod Devices Ltd. |
Ireland,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Tinnitus Handicap Inventory (THI) | Between-arm and within-arm changes in THI after 12 weeks of treatment | ||
Primary | Tinnitus Handicap Inventory (THI) | Between-arm and within-arm changes in THI after 6 weeks of treatment |
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