TES-GPS Study Protocol
Sham participants receive a brief subthreshold current for only 30 seconds followed by 0 microamps to preserve masking. TES-GPS is a prospective, randomised, double-masked, sham-controlled, monocentric pilot study with a parallel-group des…
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Sham participants receive a brief subthreshold current for only 30 seconds followed by 0 microamps to preserve masking. TES-GPS is a prospective, randomised, double-masked, sham-controlled, monocentric pilot study with a parallel-group design. The study follows ISO 14155, EU Medical Device Regulation 2017/745, ICH GCP, and the Declaration of Helsinki. The trial plans to enroll 50 patients randomised 1:1 to active TES or sham stimulation. Each participant's study duration is 18 months with up to 13 scheduled visits. The study is funded by the German Federal Ministry of Education and Research. Some study team members must remain unmasked to determine phosphene and tolerance thresholds and to program the device.