Spinal Cord Stimulation in the treatment of chronic, intractable pain using the Nalu Neurostimulation System in adults

Not Applicable

Recruiting

• Conditions: Chronic Intractable Neuropathic Pain of the legs and/or back.; Anaesthesiology - Pain management; Neurological - Other neurological disorders

• Registration Number: ACTRN12618001862235
• Lead Sponsor: alu Medical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-15
• Last Update Posted: 18 November 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Subjects between 21-80 years of age; subjects who have chronic (at least 6 months) intractable neuropathic pain of the leg and/or back; subject is unresponsive to conservative treatment options; subject has been diagnosed with failed back surgery syndrome; subject has a pain score of at least 6 on the baseline NRS pain diary; subject has stable pain medication use and dosage for at least 30 days prior to consent; subject has reported stable non-escalating pain for at least 30 days before consent.

Exclusion Criteria

Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker; subject has previously failed SCS therapy; subject has ablative procedure directed at the spinal cord including dorsal root entry zone (DREZ); subject has mechanical spinal instability detected by > 4 mm translational movement or excessive angular movement manifested by 20 degrees greater angular movement than in an adjacent segment based on flexion/extension films of lumbar spine, subject is sensitive to skin adhesives used in the system or does not tolerate wearable aspects of the device; subject has a systemic infection; subject is unable to give informed consent; subject is pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 1 year post menopausal); subject is nursing or breastfeeding; subject is > 120 mg-morphine equivalents per 24 hours.

Study & Design

• Study Type: Interventional
• Study Design: Not specified