Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)

NCT02669069 | Completed DMC

• 2 other identifiers: NeuromoddevicesTENT-A1 (Stage A1)
• Study Type: interventional
• Target: 326
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Tinnitus

Keywords

Bi-modal neuromodulation

Outcome Measures

Primary Outcomes (2)

• Tinnitus Functional Index

  Between baseline and 12 weeks

• Tinnitus Handicap Inventory

  Between baseline and 12 weeks

Study Arms (3)

PS1

ACTIVE COMPARATOR

Device: PS1

PS2

ACTIVE COMPARATOR

Device: PS2

PS3

ACTIVE COMPARATOR

Device: PS3

Interventions

PS1 DEVICE

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.

PS1

PS2 DEVICE

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.

PS2

PS3 DEVICE

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.

PS3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuromod Devices Ltd.: lead
• University Hospital Regensburg: collaborator

Study Sites (2)

University Hospital Regensburg

Regensburg, Germany

Location

St. James's Wellness Trust Clinical Research Facility

Dublin, Ireland

Location

Related Publications (2)

• 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.

  PMID: 29074518 BACKGROUND

• Conlon B, Langguth B, Hamilton C, Hughes S, Meade E, Connor CO, Schecklmann M, Hall DA, Vanneste S, Leong SL, Subramaniam T, D'Arcy S, Lim HH. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. Sci Transl Med. 2020 Oct 7;12(564):eabb2830. doi: 10.1126/scitranslmed.abb2830.

  PMID: 33028707 RESULT

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mr. Brendan Conlon

  St. James's Hospital, Ireland

  PRINCIPAL INVESTIGATOR

• Prof. Dr. med. Berthold Langguth

  University of Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: January 29, 2016
• Study Start: June 27, 2016
• Primary Completion: July 31, 2017
• Study Completion: January 30, 2019
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

IE (1); DE (1)