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Trial record 2 of 3 for:    Neuromodulation | Tinnitus | Ireland

Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

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ClinicalTrials.gov Identifier: NCT02669069
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : December 24, 2020
Sponsor:
Collaborator:
University Hospital Regensburg
Information provided by (Responsible Party):
Neuromod Devices Ltd.

Tracking Information
First Submitted Date  ICMJE January 27, 2016
First Posted Date  ICMJE January 29, 2016
Last Update Posted Date December 24, 2020
Actual Study Start Date  ICMJE June 27, 2016
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
  • Tinnitus Functional Index [ Time Frame: Between baseline and 12 weeks ]
  • Tinnitus Handicap Inventory [ Time Frame: Between baseline and 12 weeks ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
Official Title  ICMJE Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Device Feasibility
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: PS1
    Intervention: Device: PS1
  • Active Comparator: PS2
    Intervention: Device: PS2
  • Active Comparator: PS3
    Intervention: Device: PS3
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2018)
326
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 30, 2019
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02669069
Other Study ID Numbers  ICMJE Neuromoddevices
TENT-A1 (Stage A1) ( Other Identifier: Neuromod Devices Ltd. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Neuromod Devices Ltd.
Study Sponsor  ICMJE Neuromod Devices Ltd.
Collaborators  ICMJE University Hospital Regensburg
Investigators  ICMJE
Principal Investigator: Mr. Brendan Conlon St. James's Hospital, Dublin
Principal Investigator: Prof. Dr. med. Berthold Langguth University of Regensburg
PRS Account Neuromod Devices Ltd.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP