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

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

Tracking Information

• First Submitted Date: May 8, 2018
• First Posted Date: May 21, 2018
• Last Update Posted Date: September 28, 2022
• Actual Study Start Date: March 20, 2018
• Actual Primary Completion Date: October 2, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: 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: Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Tinnitus

Intervention

• 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

• 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.

Recruitment Information

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

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Ireland

Administrative Information

• NCT Number: NCT03530306
• Other Study ID Numbers: 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
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Neuromod Devices Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Neuromod Devices Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mr. Brendan Conlon; St. James's Hospital, Ireland

• PRS Account: Neuromod Devices Ltd.
• Verification Date: September 2022