MiniStim PNS Clinical Studies

The purpose of this study is to observe the efficacy of peripheral nerve stimulation utilizing a novel pIPG (MiniStim PNS) device on overall pain relief as compared to medical management over a 3-month follow-up period and the long-term efficacy of the therapy over a 36-month period in the treatment of chronic knee pain.

•1:1 randomization for medical management versus immediate activation of MiniStim PNS

•Cross-over for delayed arm, 100% of participants receive device 

•Clinical trial costs covered by sponsor 

•Commercial coverage for product and procedure related costs 

•ASC or Hospital procedure room site-of-care 

•Long term monitoring and remote follow-up  

 Inclusion Criteria:

To be eligible, subjects MUST BE/HAVE:

•Baseline VAS score of > 5 

•History chronic, function-limiting knee pain 

•≥ 50% temporary relief from nerve block diagnostics 

•No evidence of anatomic abnormalities that could jeopardize placement of the device 

Exclusion Criteria:

To be eligible, subjects must NOT BE/HAVE:

•Active implantable device ON or OFF 

•Dependency on wearable or transcutaneous monitoring device (hearing aids, glucose monitors, etc)  •< 50% relief from local nerve block diagnostics 

•Conditions requiring recurring MRI evaluation or diathermy procedures 

•Anatomical restrictions such that device placement is not possible  

The purpose of this study is to observe the efficacy of peripheral nerve stimulation utilizing a novel pIPG (MiniStim PNS) device on overall pain relief as compared to medical management over a 3-month follow-up period and the long-term efficacy of the therapy over a 36-month period in the treatment of chronic painful diabetic neuropathy.

•1:1 randomization for medical management versus immediate activation of MiniStim PNS

•Cross-over for delayed arm, 100% of participants receive device 

•Clinical trial costs covered by sponsor 

•Commercial coverage for product and procedure related costs 

•ASC or Hospital procedure room site-of-care 

•Long term monitoring and remote follow-up  

 Inclusion Criteria:

To be eligible, subjects MUST BE/HAVE:

· Subject is ≥ 18 years of age at time of informed consent;

· Subjects diagnosed with neuropathic pain from diabetic neuropathy with an average PRS (Pain Rating Scale) > 5 (on a 0-10 scale), based on the baseline pain diary

· Subject diagnosis with neuropathic pain from diabetic neuropathy refractory to conventional medical management for at least 12 months prior to enrollment

· Diagnosis with neuropathic pain in target areas by physical exam - presence of hyperalgesia, allodynia or partial sensory deficit

· Failure to obtain pain relief from at least two different classes of medication

· Based on medical opinion of Principal Investigator, subject has a stable pain medication regime for 3 months prior to study entry

· Based on medical opinion of Principal Investigator, subject has a stable Tricyclic regime for 3 months prior to study entry

· Based on medical opinion of Principal investigator, subject has a stable opioid regime with daily dose of  < 30 mg morphine equivalent

· Glucose level below 250 mg/dl

· HbA1C level below 8.5%

· No medication overuse and not attributed to causative disorder

· Based on medical opinion of Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize placement of the device or pose a hazard to the subject

· Based on medical opinion of Principal Investigator, subject is willing and able to operate the programmer, transmitter, charger, pain diary and has ability to undergo study assessments and provide accurate responses

· Based on medical opinion of implanter, subject is a good surgical subject for procedure

· Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements

· Female patients of child-bearing potential must not be pregnant and must agree to not become pregnant during the course of the study

· Patient has provided written informed consent using a form approved by the reviewing IRB.

Exclusion Criteria:

To be eligible, subjects must NOT BE/HAVE:

· An active implantable electronic device regardless of whether stimulation is ON or OFF

· Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during study

· Less than 1-year post-partum and/or are breast-feeding

· Symptoms existing for less than 6 months

· Multiple complaints that will not be amenable to study due to the overlap of pain or numbness (loss of feeling) complaints

· Current diagnosis of a Neurological disease

· Dependency on utilizing wearable or transcutaneous monitoring device (hearing aids, continuous glucose monitors, etc.)

· Conditions requiring MRI evaluation or diathermy procedures

· Uncontrolled diabetes (HbA1C 8.5 >)

· Known or suspected substance abuse within the last 2-years

· Uncontrolled major depression or uncontrolled psychiatric disorders

· Worker’s compensation claimants

· History of adverse reaction to local anesthetic drugs

· History of coagulopathy or bleeding disorder

· Anatomical restrictions such that device placement is not possible;

· Chronic or acute conditions that could interfere with the interpretations of the outcome assessment for pain and bodily function

· Have a life expectancy of less than 1-year

· Neurogenic or vascular claudication

· Evidence of any skin breakdown/infections or ulcerations

· Evidence of ulcers in feet or on legs

· Candidate has had surgery from the hip down in the last 24 weeks

· Candidate has been treated with chemotherapy in the last year

· Inability to achieve appropriate positioning and to understand informed consent

· Deemed unsuitable for enrollment by investigator based on history or physical examination

The purpose of this study is to observe the efficacy of peripheral nerve stimulation utilizing a novel pIPG (MiniStim PNS) device on overall pain relief as compared to medical management over a 3-month follow-up period and the long-term efficacy of the therapy over a 36-month period in the treatment of idiopathic hip pain.

•1:1 randomization for medical management versus immediate activation of MiniStim PNS

•Cross-over for delayed arm, 100% of participants receive device 

•Clinical trial costs covered by sponsor 

•Commercial coverage for product and procedure related costs 

•ASC or hospital procedure room site-of-care 

•Long term monitoring and remote follow-up  

 Inclusion Criteria:

To be eligible, subjects MUST BE/HAVE:

•Diagnosis of hip pain

•Baseline VAS score of >5

•>50% temporary relief from temporary nerve diagnostic evaluation

•No evidence of anatomic abnormalities that could jeopardize device placement

Exclusion Criteria:

To be eligible, subjects must NOT BE/HAVE:

•Active implantable device ON or OFF

•Symptoms existing for less than 6 months

•Current diagnosis of a Neurological disease

•Daily opioid usage exceeding CDC recommendations

•Dependency on utilizing wearable or transcutaneous monitoring device 

•Conditions requiring recurring MRI evaluation or diathermy procedures