NCT03530306

Treatment Evaluation of Neuromodulation for Tinnitus - Stage A2

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Neuromod Devices Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tinnitus

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2018-03-20
• Primary completion: 2018-10-02
• Completion: 2019-07-18
• First posted: 2018-05-21
• Last updated: 2024-12-20

Locations

1 site across 1 country: Ireland