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CompletedNCT02669069Updated Dec 20, 2024

Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

An interventional study of PS1 and PS2 in Tinnitus, sponsored by Neuromod Devices Ltd.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by Neuromod Devices Ltd. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
326
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Read the 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.

02

Conditions studied

  • Tinnitus

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Keywords

  • Bi-modal neuromodulation
03

In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's enrollment of 326 is above the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

Neuromod Devices Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
326 participants (actual)

Study arms

  • Active comparator
    PS1

    Device: PS1

  • Active comparator
    PS2

    Device: PS2

  • Active comparator
    PS3

    Device: PS3

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.

06

What researchers measure

Primary outcomes

  1. Tinnitus Functional Index

    Time frame: Between baseline and 12 weeks

  2. Tinnitus Handicap Inventory

    Time frame: Between baseline and 12 weeks

07

Study locations

2 sites
  • University Hospital Regensburg
    Regensburg, Germany
  • St. James's Wellness Trust Clinical Research Facility
    Dublin, Ireland
08

References and documents

Publications

  • 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. PubMed 29074518 ↗
  • 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. PubMed 33028707 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02669069
Lead sponsor
Neuromod Devices Ltd.
Collaborators
University Hospital Regensburg
Responsible party
Sponsor
First posted
Jan 29, 2016
Start date
Jun 27, 2016
Primary completion
Jul 31, 2017
Completion
Jan 30, 2019
Last update
Dec 20, 2024

Study contacts

Mr. Brendan Conlon
principal investigator · St. James's Hospital, Ireland
Prof. Dr. med. Berthold Langguth
principal investigator · University of Regensburg

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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