Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

Conditions

Tinnitus

Keywords

Bi-modal neuromodulation

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.

Boedts M, Buechner A, Khoo SG, Gjaltema W, Moreels F, Lesinski-Schiedat A, Becker P, MacMahon H, Vixseboxse L, Taghavi R, Lim HH, Lenarz T.

2024-08-196 citations

10.1038/s41467-024-50473-z

Feasibility of deep learning to predict tinnitus patient outcomes

Katherine S. Adcock, Gabriel Byczynski, Emma Meade, Sook Ling Leong, Richard Gault et al. (7 authors)

Intelligence-Based Medicine2024-01-011 citations

10.1016/j.ibmed.2024.100141

Bi-modal stimulation in the treatment of tinnitus: a study protocol for an exploratory trial to optimise stimulation parameters and patient subtyping

Shona D’Arcy, Caroline Hamilton, Stephen G. Hughes, Deborah A. Hall, Sven Vanneste et al. (7 authors)

BMJ Open2017-10-0119 citations

10.1136/bmjopen-2017-018465

Interventions

DEVICEPS1

Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are synchronous with the tones.

DEVICEPS2

Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones.

DEVICEPS3

Participants in this arm shall be given an audio stimulus which comprises of a sequence of single-frequency tones mixed with a broadband noise with the frequency characteristics of both chosen outside the region of any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Tinnitus Functional Index	Between baseline and 12 weeks
Tinnitus Handicap Inventory	Between baseline and 12 weeks

Countries

Germany, Ireland

Outcome results

None listed