NCT03954080

Trialing of ISS in Patients With CRPS

Trialing of Intra-spinal Stimulation in Patients With Complex Regional Pain Syndrome or Causalgia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Millennium Pain Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective, open-label, single-arm, observational, feasibility study. The goal of this study is to determine the feasibility of intra-spinal stimulation with optimal paresthesia coverage therapy for chronic pain relief in patients with complex regional pain syndrome type I or causalgia. Up to 20 patients with intractable chronic severe limb pain associated with complex regional pain syndrome (CRPS) will be included in the study. A standard of care trial phase to test a subjects' response to Intraspinal-Optimal Stim therapy will be conducted during a 3 to 10-day period. Patients that obtain 50% or greater pain relief during the trial period will undergo permanent implantation of the device. Primary outcome will evaluate pain response at 3 months of therapy, based on NPRS pain score relative to baseline. Patients will be followed up for 6 months after the start of therapy.

Conditions

• CRPS I
• Causalgia

Interventions

Type	Name	Description
DEVICE	Intraspinal-optimal stim therapy	During the trial, percutaneous lead(s) will be implanted, following standard clinical practices, in the posterior epidural space with the final lead position located in the optimal area to provide pain relief by stimulating neural tissue in order to create paresthesia(s) only on the painful dermatome(s). During Intraspinal-Optimal Stim, a set of electrodes in the stimulation lead(s) will deliver a charge-balanced, pulsed electrical signal with stimulation parameters (frequency, pulse width, and amplitude) within the FDA approved specifications of the commercially available external neurostimulator. These will be adjusted to produce paresthesia coverage of the painful area. Patients that will report equal or greater than 50% reduction in pain, relative to baseline pain, may undergo permanent implantation of a commercially available neurostimulator (INS). This will require a surgical intervention to implant stimulation leads, INS and anchoring hardware followed by therapy programming.

Timeline

• Start date: 2019-06-13
• Primary completion: 2022-03-23
• Completion: 2022-03-31
• First posted: 2019-05-17
• Last updated: 2022-04-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study