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

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

This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

Study Overview

• Status: Completed
• Conditions: Tinnitus
• Intervention / Treatment: Device: PS1-PS4; Device: PS6-PS10; Device: PS7-PS4; Device: PS9-PS6

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: Interventional
• Enrollment (Actual): 191
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • St. James's Wellness Trust Clinical Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Tinnitus Handicap Inventory (THI)	Between-arm and within-arm changes in THI after 6 weeks of treatment

Other Outcome Measures

Outcome Measure	Time Frame
Tinnitus Handicap Inventory (THI)	Between-arm and within-arm changes in THI after 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Neuromod Devices Ltd.
• Investigators: Principal Investigator: Mr. Brendan Conlon, St. James's Hospital, Dublin

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): October 2, 2018
• Study Completion (Actual): July 18, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 21, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: Neuromoddevices TENT-A2

Drug and device information, study documents

• 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