The medical appliance industry has long been source of potentially very lucrative investments. When a company first develops an innovation, taking a gamble on its viability and eventual sales can pay rich rewards. That is why financial news outlets often report on new medical appliances when those appliances reach the clinical trial phase, a big step towards entry into the market. This morning, the financial publication Business Wire published this news under the headline “Stimwave’s Spinout Enrolls First Patient in Drug-Free Chronic Craniofacial Nerve Pain Study Utilizing the World’s Smallest Wireless Neurostimulator“:
StimRelieve LLC, a privately held, pre-commercial stage medical device company, today announced the initiation and the first patient enrollment in a clinical trial of the world’s first implantable device for the treatment of chronic craniofacial nerve pain.
[Editor’s note: StimRelieve is taking some liberties with this last sentence. There are other implantable devices for facial pain that predate StimRelieve, such as motor cortex stimulators and other devices similar to StimRelieve. What makes this product unique is the fact that it is wireless, enabling the patient to avoid the previously necessary electrical leads to devices outside the body from the stimulator implanted inside the body.]
The StimRelieve device utilizes wireless technology and is placed through an introducer device the size of a needle 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 a variety of modalities, including, but not limited to, 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.
“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 details of the clinical trial, including how to submit an application to participate, can be found here at ClinicalTrials.gov. They are actively recruiting test subjects and will only take fifty (50.)
Inclusion Criteria:
- Subject is ≥ 18 years of age at time of informed consent
- Subjects have been diagnosed with Cranial-facial pain with an average VAS > 5 (on a 0-10 scale) over the course of the last month based on baseline pain diary.
- Subject diagnosis with neuropathic cranial-facial pain refractory to conventional medical management for at least 12 months prior to enrollment;
- Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regimen for 3 months prior to study entry.
- Based on the medical opinion of the Principal Investigator, subject has a stable Tricyclic regimen for 3 months prior to study entry
- No medication overuse and not attributed to another causative disorder
- Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
- Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
- Based on the opinion of the implanter, subject is a good surgical subject for the implant procedure;
- Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
- Subject is male or non-pregnant female as determined with a negative pregnancy test at baseline visit, and if sexually active, must be using a medically acceptable method of contraception for the duration of their study participation;
- Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures;
- Patient is capable of giving informed consent
Exclusion Criteria:
- Subject has undergone botulinum toxin (BOTOX) injections of the head and/or neck in the last 3 months.
- Unresolved Malignancies in last six months;
- Subject has a history of migraine, headaches of central origin, or trigeminal autonomic cephalalgias;
- Subject has postherpetic neuralgia (shingles);
- Complete deafferentation of all branches of the trigeminal, facial, occipital nerves and cervical plexus;
- Subject has an active systemic infection or is immune-compromised;
- Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
- Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
- Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
- Bleeding complications or coagulopathy issues;
- Pregnant/lactating or not using adequate birth control;
- A life expectancy of less than one year;
- Any active implanted device whether turned off or on;
- A previous peripheral nerve stimulator (PNS) experience for the treatment of facial pain including a failed trial or explanted device;
- Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures;
- Subject is currently involved in litigation regarding injury, or is receiving worker’s compensation benefits.