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

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: NCT03530306
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Neuromod Devices Ltd.

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

Condition or disease Intervention/treatment Phase
Tinnitus Device: PS1-PS4 Device: PS6-PS10 Device: PS7-PS4 Device: PS9-PS6 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2 (TENT-A2)
Actual Study Start Date : March 20, 2018
Actual Primary Completion Date : October 2, 2018
Actual Study Completion Date : July 18, 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-PS4 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.
Active Comparator: PS6-PS10 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.
Active Comparator: PS7-PS4 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.
Active Comparator: PS9-PS6 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.


Outcome Measures
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Primary Outcome Measures :
  1. Tinnitus Handicap Inventory (THI) [ Time Frame: Between-arm and within-arm changes in THI after 6 weeks of treatment ]

Other Outcome Measures:
  1. Tinnitus Handicap Inventory (THI) [ Time Frame: Between-arm and within-arm changes in THI after 12 weeks of treatment ]

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:

  • 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
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): NCT03530306


Locations
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Ireland
St. James's Wellness Trust Clinical Research Facility
Dublin, Ireland
Sponsors and Collaborators
Neuromod Devices Ltd.
Investigators
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Principal Investigator: Mr. Brendan Conlon St. James's Hospital, Ireland
More Information
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Publications:

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Responsible Party: Neuromod Devices Ltd.
ClinicalTrials.gov Identifier: NCT03530306    
Other Study ID Numbers: Neuromoddevices TENT-A2
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases