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

Primary Purpose

Tinnitus

Status

Completed

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

PS1-PS4

PS6-PS10

PS7-PS4

PS9-PS6

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. James's Wellness Trust Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

PS1-PS4

PS6-PS10

PS7-PS4

PS9-PS6

Arm Description

Outcomes

Primary Outcome Measures

Tinnitus Handicap Inventory (THI)

Secondary Outcome Measures

Full Information

NCT ID

NCT03530306

First Posted

May 8, 2018

Last Updated

September 26, 2022

Sponsor

Neuromod Devices Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03530306

Brief Title

Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2

Acronym

TENT-A2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 20, 2018 (Actual)

Primary Completion Date

October 2, 2018 (Actual)

Study Completion Date

July 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neuromod Devices Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tinnitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

191 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PS1-PS4

Arm Type

Active Comparator

Arm Title

PS6-PS10

Arm Type

Active Comparator

Arm Title

PS7-PS4

Arm Type

Active Comparator

Arm Title

PS9-PS6

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

PS1-PS4

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

PS6-PS10

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

PS7-PS4

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

PS9-PS6

Intervention Description

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.

Primary Outcome Measure Information:

Title

Tinnitus Handicap Inventory (THI)

Time Frame

Between-arm and within-arm changes in THI after 6 weeks of treatment

Other Pre-specified Outcome Measures:

Title

Tinnitus Handicap Inventory (THI)

Time Frame

Between-arm and within-arm changes in THI after 12 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mr. Brendan Conlon

Organizational Affiliation

St. James's Hospital, Ireland

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. James's Wellness Trust Clinical Research Facility

City

Dublin

Country

Ireland

12. IPD Sharing Statement

Citations:

PubMed Identifier

31573942

Citation

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.

Results Reference

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Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2

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