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Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2 (TENT-A2)

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ClinicalTrials.gov Identifier: NCT03530306
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Neuromod Devices Ltd.

Tracking Information
First Submitted Date  ICMJE May 8, 2018
First Posted Date  ICMJE May 21, 2018
Last Update Posted Date December 24, 2020
Actual Study Start Date  ICMJE March 20, 2018
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
Tinnitus Handicap Inventory (THI) [ Time Frame: Between-arm and within-arm changes in THI after 6 weeks of treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 8, 2018)
Tinnitus Handicap Inventory (THI) [ Time Frame: Between-arm and within-arm changes in THI after 12 weeks of treatment ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2
Official Title  ICMJE Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2 (TENT-A2)
Brief Summary This is a four 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. Participants are randomized to one of four different treatment arms. The treatment period is intended for 12 weeks of use. Based on the clinical investigation plan, participants are informed that their stimulation settings can change between the first and second halves of the treatment period and that the differences may be perceptually noticeable. Differences in tinnitus severity scores will be compared between and within treatment arms.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • Device: PS1-PS4
    Participants in this arm shall be given PS1 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
  • Device: PS6-PS10
    Participants in this arm shall be given PS6 during the first half of treatment and PS10 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
  • Device: PS7-PS4
    Participants in this arm shall be given PS7 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
  • Device: PS9-PS6
    Participants in this arm shall be given PS9 during the first half of treatment and PS6 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
Study Arms  ICMJE
  • Active Comparator: PS1-PS4
    Intervention: Device: PS1-PS4
  • Active Comparator: PS6-PS10
    Intervention: Device: PS6-PS10
  • Active Comparator: PS7-PS4
    Intervention: Device: PS7-PS4
  • Active Comparator: PS9-PS6
    Intervention: Device: PS9-PS6
Publications * Conlon B, Hamilton C, Hughes S, Meade E, Hall DA, Vanneste S, Langguth B, Lim HH. Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters. JMIR Res Protoc. 2019 Sep 27;8(9):e13176. doi: 10.2196/13176.

*   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: April 27, 2019)
191
Original Estimated Enrollment  ICMJE
 (submitted: May 8, 2018)
192
Actual Study Completion Date  ICMJE July 18, 2019
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 70 years of age
  • Ability to read and understand English
  • Willing and able to provide informed consent
  • Willing to commit to the full duration of the study
  • Baseline Tinnitus Handicap Inventory (THI) score of >= 38 points
  • Subjective tinnitus of 3 months to 10 years
  • Maximum AC pure-tone audiometry hearing loss of 80 dB HL in any test frequency in the set {2,3,4,6,8}kHz or 40 dB HL in the set {250,500,1000}Hz either unilaterally or bilaterally
  • Baseline Minimum Masking Level (MML) of 20 to 80 dB HL
  • Tonal tinnitus

Exclusion Criteria:

  • 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 Minimum Masking Level (MML) assessment
  • Meniere's disease
  • Significantly severe Loudness Discomfort Level (LDL, less than 30 dB SL)
  • Depression or neuro-psychological condition, previously diagnosed or identified from the State-Trait Anxiety Inventory (STAI) with score 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 condition 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)
  • Patient with a pacemaker or other electro-active implanted device
  • 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
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03530306
Other Study ID Numbers  ICMJE Neuromoddevices TENT-A2
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 Not Provided
Investigators  ICMJE
Principal Investigator: Mr. Brendan Conlon St. James's Hospital, Dublin
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