Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02669069 |
Recruitment Status :
Completed
First Posted : January 29, 2016
Last Update Posted : December 24, 2020
|
Sponsor:
Neuromod Devices Ltd.
Collaborator:
University Hospital Regensburg
Information provided by (Responsible Party):
Neuromod Devices Ltd.
Tracking Information | |||||||
---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | January 27, 2016 | ||||||
First Posted Date ICMJE | January 29, 2016 | ||||||
Last Update Posted Date | December 24, 2020 | ||||||
Actual Study Start Date ICMJE | June 27, 2016 | ||||||
Actual Primary Completion Date | July 31, 2017 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
|
||||||
Original Primary Outcome Measures ICMJE | Not Provided | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A) | ||||||
Official Title ICMJE | Treatment Evaluation of Neuromodulation for Tinnitus (TENT-A) | ||||||
Brief Summary | This is a three 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. 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 Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Device Feasibility |
||||||
Condition ICMJE | Tinnitus | ||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
326 | ||||||
Original Enrollment ICMJE | Not Provided | ||||||
Actual Study Completion Date ICMJE | January 30, 2019 | ||||||
Actual Primary Completion Date | July 31, 2017 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||
Sex/Gender ICMJE |
|
||||||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Germany, Ireland | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02669069 | ||||||
Other Study ID Numbers ICMJE | Neuromoddevices TENT-A1 (Stage A1) ( Other Identifier: Neuromod Devices Ltd. ) |
||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Current Responsible Party | Neuromod Devices Ltd. | ||||||
Original Responsible Party | [Redacted] | ||||||
Current Study Sponsor ICMJE | Neuromod Devices Ltd. | ||||||
Original Study Sponsor ICMJE | [Redacted] | ||||||
Collaborators ICMJE | University Hospital Regensburg | ||||||
Investigators ICMJE |
|
||||||
PRS Account | Neuromod Devices Ltd. | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |