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| ID | Type | Description | Link |
|---|---|---|---|
| TENT-A1 (Stage A1) | Other Identifier | Neuromod Devices Ltd. |
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| Name | Class |
|---|---|
| University Hospital Regensburg | OTHER |
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This is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS1 | Active Comparator |
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| PS2 | Active Comparator |
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| PS3 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tinnitus Functional Index | Between baseline and 12 weeks | |
| Tinnitus Handicap Inventory | Between baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mr. Brendan Conlon | St. James's Hospital, Ireland | Principal Investigator |
| Prof. Dr. med. Berthold Langguth | University of Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Regensburg | Regensburg | Germany | ||||
| St. James's Wellness Trust Clinical Research Facility |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29074518 | Background | 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. | |
| 33028707 | Result |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| 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. |
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| 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. |
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| Dublin |
| Ireland |
| 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. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |