Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

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

Tracking Information

• First Submitted Date: January 27, 2016
• First Posted Date: January 29, 2016
• Last Update Posted Date: December 24, 2020
• Actual Study Start Date: June 27, 2016
• Actual Primary Completion Date: July 31, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Device Feasibility
• Condition: Tinnitus

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 29, 2018): 326
• Original Enrollment: Not Provided
• Actual Study Completion Date: January 30, 2019
• Actual Primary Completion Date: July 31, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• 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: Germany, Ireland

Administrative Information

• NCT Number: NCT02669069
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: Neuromod Devices Ltd.
• Original Responsible Party: [Redacted]
• Current Study Sponsor: Neuromod Devices Ltd.
• Original Study Sponsor: [Redacted]
• Collaborators: University Hospital Regensburg

Investigators

• 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