NCT03530306|CompletedDMC
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2
TENT-A2
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TENT-A2
Sponsor study identifier
interventional
191
1 country
1
Study Start
March 20, 2018
Actual (reported)Primary Completion
October 2, 2018
Actual (reported)Study Completion
July 18, 2019
Actual (reported)This is a four arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 18, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 20, 2018
Actual (reported)May 8, 2018
Actual (reported)May 21, 2018
Actual (reported)October 2, 2018
Actual (reported)July 18, 2019
Actual (reported)Tinnitus Handicap Inventory (THI)
Between-arm and within-arm changes in THI after 6 weeks of treatment
Tinnitus Handicap Inventory (THI)
Between-arm and within-arm changes in THI after 12 weeks of treatment
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.
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.
St. James's Wellness Trust Clinical Research Facility
Dublin, Ireland
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.
Mr. Brendan Conlon
St. James's Hospital, Ireland
191 participants (actual enrollment reported by the registry).
First Submitted
May 8, 2018
First Posted
May 21, 2018
Study Start
March 20, 2018
Actual (reported)The Longer, the Better? Investigating the Effect of Prolonged Acoustic Stimulation on Brief Acoustic Tinnitus Suppression
Acoustic and Electrical Stimulation for the Treatment of Tinnitus
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
October 2, 2018
Actual (reported)Study Completion
July 18, 2019
Actual (reported)Last Updated
December 20, 2024
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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