NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators

Brief summary (from the registry)

The primary objective is to demonstrate the safety and efficacy of a non-awake implantation method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter, parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will be implanted from up to 4 active sites, coordinated by a single lead investigator. Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.

Study details

Official title

NAPS (Non-awake Versus Awake Placement of Spinal Cord Stimulators) Study for the Evaluation of Awake and Non-awake Methods of SCS Paddle Lead Placement

Conditions

• Chronic Pain
• Sciatica
• Failed Back Surgery Syndrome

Interventions

• Procedure: Awake
• Procedure: Non-Awake

Sponsor

St. Luke's Hospital, Pennsylvania

Collaborators

Abbott Medical Devices

Start date

2014-11-01

Primary completion

2017-01-31

Sex

All

Age range

from 18 Years

Results posted

No results posted in this snapshot

Countries

United States

Total sites listed

4

Eligibility criteria