This is a four 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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
191
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.
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.
St. James's Wellness Trust Clinical Research Facility
Dublin, Ireland
Tinnitus Handicap Inventory (THI)
Time frame: Between-arm and within-arm changes in THI after 6 weeks of treatment
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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.