Neuronoff announced it completed the first-in-human clinical trial evaluating its flagship Injectrode neuromodulation product. The Cleveland-based company designed Injectrode to treat chronic pain. The LIFE (lumbar Injectrode feasibility evaluation) trial evaluated Injectrode’s safety and effectiveness, meeting all goals, the company said. Injectrode placement comes through an 18-gauge needle (no incisions) under local analgesia at the level of the skin and subdermis. Doctors determine placement location using fluoroscopic visualization then confirm it with electrical test stimulation during placement.
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According to a news release, 10 participants received Injectrodes (injectable electrodes) placed unilaterally or bilaterally near the dorsal rami innervation to the erector spinae and multifidus muscles in the lower back for less than 30 days. Peripheral nerve stimulation of the dorsal rami may provide afferent input to the spinal circuitry. In turn, this initiates neuromodulatory and rehabilitative treatment of non-radiating, axial and facetogenic lower back pain.
The trial demonstrated the feasibility of the transcutaneous stimulation. Neuronoff said it indicated the Injectrode’s ability to deliver electrical neuromodulation at typical therapeutic levels from an external pulse generator across the skin all the way to the lumbar dorsal rami. This drives the activation of all part of the erector spinae (iliocostalis, longissimus and spinalis) and multifidus muscles.
Injectrode also maintained a strong safety profile throughout. Neuronoff reported no serious adverse events and no post-insertion analgesics or sutures.
“The study comprised a major leap forward for the development of the Injectrode, providing valuable information that builds upon the company’s prior preclinical testing, including assessment of tolerability of sensory perception during stimulation, and first-in-human feasibility of the Injectrode’s transcutaneous stimulation approach,” Neuronoff Chief Scientific Officer Andrew Shoffstall said.
