A prospective, feasibility study evaluating the safety and effectiveness of Saluda Medical’s Neurostimulation Technology incorporating neural response measurement and feedback control to treat patients with chronic pain in an extended trial

Not Applicable

Completed

• Conditions: Chronic pain; Anaesthesiology - Pain management; Neurological - Other neurological disorders

• Registration Number: ACTRN12614000684628
• Lead Sponsor: Saluda Medical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Patients enrolled in this study must meet the following inclusion criteria:
1.Have been diagnosed with chronic, intractable pain, which has been refractory to conservative therapy for a minimum of 3 months.
2.Have been approved to undergo a trial of neural stimulation. Neural stimulation can include spinal cord stimulation (cervical, thoracic or sacral), peripheral nerve stimulation (such as occipital or sacral nerves), dorsal root, or dorsal root ganglion.
3.Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
4.Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial
5.Be 18 years of age or older at the time of enrolment
6.Be willing and capable of giving written informed consent
7.Be willing and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria

Patients enrolled in this study must not meet the following exclusion criteria:
1.Have a medical condition or pain in area(s) 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 perception of pain, compliance of intervention and/or ability to evaluate treatment outcomes
3.Have a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
4.Have a diagnosis of scoliosis that precludes lead placement in epidural space (for SCS patients only)
5.Have an existing drug pump and/or neural stimulation system or another active implantable device such as a pacemaker
6.Have a condition currently requiring or likely to require the use of MRI or diathermy
7.Have pain due to a malignant disease
8.Have a life expectancy of less than 1 year
9.Have an active systemic or local infection
10.Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
11.Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
12.Have within 6 months of enrolment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and/or illicit drugs)
13.Be concomitantly participating in another clinical study
14.Be involved in an injury claim under current litigation

Study & Design

• Study Type: Interventional
• Study Design: Not specified