Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

• Sponsor: Neuromod Devices Ltd.
• Collaborator: University Hospital Regensburg
• Information provided by (Responsible Party): Neuromod Devices Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Tinnitus	Device: PS1; Device: PS2; Device: PS3	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 326 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Device Feasibility
• Official Title: Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
• Actual Study Start Date: April 22, 2016
• Actual Primary Completion Date: July 27, 2017
• Estimated Study Completion Date: July 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: PS1	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.
Active Comparator: PS2	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.
Active Comparator: PS3	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.

Outcome Measures

Primary Outcome Measures :

1. Tinnitus Functional Index [ Time Frame: Between baseline and 12 weeks ]
2. Tinnitus Handicap Inventory [ Time Frame: Between baseline and 12 weeks ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Aged over 18 and under 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 more than 3 months and less than 5 years
• Experiencing subjective tinnitus
• Baseline Tinnitus Handicap Inventory (THI) score between 28 and 76 points
• Baseline Minimum Masking Level (MML) between 20 and 80dBHL
• Maximum AC pure-tone audiometry hearing loss of 80dB HL at any test frequencies in the region of 250Hz to 8kHz or 40 dB HL in the set {250,500,1k} 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), <30dB 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

Contacts and Locations

Locations

Germany

University Hospital Regensburg

Regensburg, Germany

Ireland

St. James's Wellness Trust Clinical Research Facility

Dublin, Ireland

Sponsors and Collaborators

Neuromod Devices Ltd.

University Hospital Regensburg

Investigators

• Principal Investigator: Mr. Brendan Conlon; St. James's Hospital, Dublin
• Principal Investigator: Prof. Dr. med. Berthold Langguth; University of Regensburg

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Neuromod Devices Ltd.
• ClinicalTrials.gov Identifier: NCT02669069 History of Changes
• Other Study ID Numbers: Neuromoddevices; TENT-A1 (Stage A1) ( Other Identifier: Neuromod Devices Ltd. )
• First Posted: January 29, 2016
• Last Update Posted: April 30, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Neuromod Devices Ltd.:

Bi-modal neuromodulation

Additional relevant MeSH terms:

Tinnitus; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms