Patient enrollment for a clinical trial of the first implantable device for the treatment of craniofacial nerve pain has begun, according to a press release from the company conducting the trial, StimRelieve, LLC.”
Why no other product was ever really practical for placement in the head was due to the need for extensive tunneling down the neck with connection to an implanted pulse generator system. Now, for the first time ever, patients in this trial have an option for wireless stimulation for potential pain relief from various modalities that are impacting their quality of life,” said Richard Weiner, MD, of Dallas Neurosurgical and Spine Associates, the developer of occipital (ONS) stimulation.
The device to be tested in the clinical trial utilizes wireless technology and is placed through a needle-like introducer near the inflicted painful nerves to modulate nerve activity and provide therapeutic relief. The study is focused on patients afflicted with neuropathic pain of the face, head or neck, which can result from trigeminal neuropathy, postherpetic neuralgia, trigeminal or occipital neuralgias, facial or neck trauma, oral, facial or dental surgery, infections, whiplash, TMJ, or even atypical facial pain.
Epidemiologists estimate that approximately 39 million adult Americans have some degree of ongoing chronic craniofacial pain. A large number of these pain suffers are completely “undiagnosable,” making treatment very difficult.
“The development of a minimally invasive implantable neuromodulation system targeting craniofacial nerves has the potential to help patients suffering from facial pain without the added complexity associated with extension cables and implantable pulse generators,” said Dr. Ashwin Viswanathan, Baylor College of Medicine, Houston, Texas, a recognized authority on facial pain.
“StimRelieve’s technology has the potential to be that innovation,” he said. Dr. Viswanathan serves as the Principal Investigator at Baylor College of Medicine, the site that enrolled the first patient.
The study will include approximately 50 patients, and will be randomized, controlled study that compares the efficacy of the device as opposed to receiving no stimulation. This clinical trial will focus on implanting a small neurostimulator at craniofacial nerves under ultrasound guidance and utilizing a discreetly worn external transmitter to provide energy and therapy to the implanted device. The clinical trial will assess the effectiveness of delivering pulsed electrical energy to the targeted craniofacial nerve for the treatment of chronic pain.
“If the safety and effectiveness of the device is successfully trialed, the StimRelieve technology would allow neuromodulation to be offered to an underserved population living with chronic refractory craniofacial pain as a viable alternative to drug based therapy,” said Laura Tyler Perryman, managing director and co-founder of StimRelieve. “The StimRelieve solution proposes a treatment option that is simple and not intimidating for patients. We look forward to the potential of positive results from the study on the path to bring this technology to market.”