Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2
NCT ID: NCT03530306
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
191 participants
INTERVENTIONAL
2018-03-20
2019-07-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PS1-PS4
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.
PS6-PS10
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.
PS7-PS4
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.
PS9-PS6
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Neuromod Devices Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Mr. Brendan Conlon
Role: PRINCIPAL_INVESTIGATOR
St. James's Hospital, Ireland
Locations
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St. James's Wellness Trust Clinical Research Facility
Dublin, , Ireland
Countries
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References
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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.
Conlon B, Hamilton C, Meade E, Leong SL, O Connor C, Langguth B, Vanneste S, Hall DA, Hughes S, Lim HH. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Sci Rep. 2022 Jun 30;12(1):10845. doi: 10.1038/s41598-022-13875-x.
Other Identifiers
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Neuromoddevices TENT-A2
Identifier Type: -
Identifier Source: org_study_id