Validation of positional data in the Intellis implantable neurostimulator in patients with neuropathic pain.

Precision Health Foundation0 个研究点目标入组 25 人开始时间: 2019年5月16日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•1.adult patients (18 to 70 years of age)
•2.diagnosed with chronic intractable pain of the lower back and/or leg (s)
•3.have passed a neuropsychological screen as per standard of care for SCS
•4.have opted to undergo permanent SCS implant
•5.able to move freely between sitting, standing, lying and walking positions unassisted
•6.be willing and capable of giving informed consent
•7.be willing and able to comply with study-related requirement, procedures and visits
•8.females of childbearing age must have a negative urine pregnancy test at baseline (if female and sexually active, participant must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)

•1.have a medical condition or pain in other area (s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
•2.have evidence of an active, disruptive psychological or psychiatric disorder or other known condition significant enough to impact mobility, severe sleep disturbance, compliance of intervention and/or ability to evaluate treatment outcomes
•3.have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
•4.have a condition currently requiring or likely to require the use of MRI or diathermy
•5.have been diagnosed with a malignancy or has an active systemic infection
•6.be pregnant or nursing
•7.have within 6 months of enrolment a significant untreated addiction to dependency producing medications or have been a substance abuser
•8.are under active worker’s compensation (or personal injury) litigation or adjudication

发起方

Precision Health Foundation