). The device was programmed using a customized software package to interface with other devices and to implement protocol treatment requirements. Somatosensory stimulation was provided by 2 transcutaneous active electrodes positioned on the skin overlying the trigeminal ganglion or the C1 and C2 cervical spinal cord with the ground electrode adjacent. Electrode placement was determined by somatic-maneuver evaluations.The current level was titrated to the participant’s sensation threshold.
After training, participants used the device for 30 minutes per day for the duration of a treatment phase. Device use was logged and analyzed for compliance at every in-laboratory visit. Tinnitus was monitored throughout the study, and participants were withdrawn if both of their TFI scores for the same 2 consecutive weeks increased 12 points over the baseline level and if their mean tinnitus loudness level increased 16 dB .
and the present studies, all participants reported quickly habituating to the electrical stimulus, which was close to threshold, making the stimulus difficult to detect. Participants stated that they could not tell whether they were receiving the control or active treatment.were extrapolated linearly from 4 to 6 weeks to estimate effect sizes. We hypothesized that participants receiving active treatments would show greater reductions in outcome measure slope than control participants.
Age at enrollment, sex, and COVID-19 lockdown time were controlled for as covariates. Continuous variables were summarized by the means and SDs or 95% CIs. Treatment phase was used as the within-participant factor, and group was used as the between-participant factor to compare differences in the means between treatment groups.