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Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PS1
PS2
PS3
Sponsored by
Neuromod Devices Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Bi-modal neuromodulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Regensburg
  • St. James's Wellness Trust Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

PS1

PS2

PS3

Arm Description

Outcomes

Primary Outcome Measures

Tinnitus Functional Index
Tinnitus Handicap Inventory

Secondary Outcome Measures

Full Information

First Posted
January 27, 2016
Last Updated
September 26, 2022
Sponsor
Neuromod Devices Ltd.
Collaborators
University Hospital Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT02669069
Brief Title
Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
Official Title
Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 27, 2016 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuromod Devices Ltd.
Collaborators
University Hospital Regensburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Bi-modal neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
326 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PS1
Arm Type
Active Comparator
Arm Title
PS2
Arm Type
Active Comparator
Arm Title
PS3
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
PS1
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PS2
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PS3
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tinnitus Functional Index
Time Frame
Between baseline and 12 weeks
Title
Tinnitus Handicap Inventory
Time Frame
Between baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mr. Brendan Conlon
Organizational Affiliation
St. James's Hospital, Ireland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Dr. med. Berthold Langguth
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Regensburg
City
Regensburg
Country
Germany
Facility Name
St. James's Wellness Trust Clinical Research Facility
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
29074518
Citation
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.
Results Reference
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Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

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