Craniofacial Nerve Pain Study Utilizing Smallest Wireless Neurostimulator Underway

Craniofacial Nerve Pain Study Utilizing Smallest Wireless Neurostimulator Underway

By Staff

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.”

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Authored by: Staff

There are 6 comments for this article
  1. Kathy Jackson at 3:18 pm

    I have lived with atypical facial pain for about seven years now and my question would be; what if the device does not relieve your pain? Does it work for any type of face pain? Would like to have more information on this subject and would even like to be considered for some trials.

  2. Ellen Falvey at 7:43 am

    Becky, I truly understand your pain. The sharp, shooting, electric-like pain can just happen. It is guaranteed to happen if someone touches my face, I brush my teeth or even I get a gust of wind. Let’s hope this passes trials and can help us. God Bless. Ellen

  3. Becky at 1:20 pm

    Sharp lighting pain ,have pulled over half of my teeth. Now left side of head,neck, ear gets hot.it feels like someone turned on a stove eye and heats up ,comes on withturnof head and neck mostly. Sharp pain just happens

  4. ellen Falvey at 2:39 pm

    I have trigeminal Neuralgia and have been deemed refractory to all medications. I’ve had two gamma knife radio surgeries and tried all the “alternative” remedies. I had a disastrous and unsuccessful “procedure on 11/4/16. It was supposed to be a 1-1/2 hour surgery with 72 hours recovery in the hospital. The surgeon said that if I allowed him to make a quarter size hole behind my ear that he would be able to find what the MRI’s didn’t show and fix it (basically a MVD). To make a long story short, it turned into a 6 -1/2 hour full craniotomy, 6 weeks in a coma and 2 months in a Rehab facility. I got home on 2/14/17 and just graduated from VNA services this past Thursday.

    The pain is still here and worsening day by day. I would really appreciate it if you would consider me for your trials.

    Thank you

  5. david at 9:46 am

    This a treatment that ignores causes and contributing factors. It is the same old pain is in the brain neurocentric neurobiologism that hasnt lowered the prevalence of people in pain but rather prefers to boast of improving lives.

  6. Ramona Fiorentino at 4:16 am

    That is incredible science has come up with I think that’s a fantastic idea even though I don’t need it but I’m sure a lot of people do do

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