ID: 217021 An Injectable Helical Structure (DRG F1 Injectrode) Clinical Trial to Demonstrate Paresthesia in Healthy Subjects

Existing DRG trial lead placement requires an invasive procedure, results in lead protrusion from the skin after placement, and is cumbersome to the patient. Neuromodulation solutions are often perceived as a “last resort” solution, and early intervention has been associated with improved patient outcomes. Thus, there is a need for a short-term trial lead that can be completely injected into the body with a minimally invasive procedure, with no external lead “tails” protruding from the skin. Upon placement, external TENS stimulation is provided through patches attached to the skin via the device’s increased surface area and flexible helical structure. Here, we present the design of a non-significant risk clinical trial to assess safety and tolerability of paresthesia perception via TENS stimulation of the DRG F1 Injectrode.