Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

September 26, 2022 updated by: Neuromod Devices Ltd.
This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

326

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PS1
Device: PS1
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.
Active Comparator: PS2
Device: PS2
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.
Active Comparator: PS3
Device: PS3
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tinnitus Functional Index
Time Frame: Between baseline and 12 weeks
Between baseline and 12 weeks
Tinnitus Handicap Inventory
Time Frame: Between baseline and 12 weeks
Between baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuromod Devices Ltd.

Collaborators

University Hospital Regensburg

Investigators

  • Principal Investigator: Mr. Brendan Conlon, St. James's Hospital, Dublin
  • Principal Investigator: Prof. Dr. med. Berthold Langguth, University of Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2016

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

January 27, 2016

First Submitted That Met QC Criteria

January 28, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 26, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuromoddevices
  • TENT-A1 (Stage A1) (Other Identifier: Neuromod Devices Ltd.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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