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Trial record 2 of 3 for:    Neuromodulation | Tinnitus | Ireland
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Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02669069
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
University Hospital Regensburg
Information provided by (Responsible Party):
Neuromod Devices Ltd.

Study Description
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Brief Summary:
This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Condition or disease Intervention/treatment Phase
Tinnitus Device: PS1 Device: PS2 Device: PS3 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
Actual Study Start Date : April 22, 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Tinnitus Functional Index [ Time Frame: Between baseline and 12 weeks ]
  2. Tinnitus Handicap Inventory [ Time Frame: Between baseline and 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged over 18 and under 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 more than 3 months and less than 5 years
  • Experiencing subjective tinnitus
  • Baseline Tinnitus Handicap Inventory (THI) score between 28 and 76 points
  • Baseline Minimum Masking Level (MML) between 20 and 80dBHL
  • Maximum AC pure-tone audiometry hearing loss of 80dB HL at any test frequencies in the region of 250Hz to 8kHz or 40 dB HL in the set {250,500,1k} 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), <30dB 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669069


Locations
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Germany
University Hospital Regensburg
Regensburg, Germany
Ireland
St. James's Wellness Trust Clinical Research Facility
Dublin, Ireland
Sponsors and Collaborators
Neuromod Devices Ltd.
University Hospital Regensburg
Investigators
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Principal Investigator: Mr. Brendan Conlon St. James's Hospital, Dublin
Principal Investigator: Prof. Dr. med. Berthold Langguth University of Regensburg
More Information
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Publications:

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Responsible Party: Neuromod Devices Ltd.
ClinicalTrials.gov Identifier: NCT02669069    
Other Study ID Numbers: Neuromoddevices
TENT-A1 (Stage A1) ( Other Identifier: Neuromod Devices Ltd. )
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neuromod Devices Ltd.:
Bi-modal neuromodulation
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms