Trials / Completed
CompletedNCT02514590
Wireless Spinal Cord Stimulation for Chronic Pain
Multi-center, Prospective, Clinical Trial of Wireless Spinal Cord Stimulation in the Treatment of Chronic Pain
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Curonix LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain
Detailed description
This is a multi-center, prospective study in which subjects will receive a Freedom SCS System and to receive stimulation at a frequency between 5 Hz to 1500 Hz . Enrollment will continue until 49 subjects have been implanted. Subjects will have chronic back or back and leg pain refractory to standard medical treatment associated with Failed Back Surgery Syndrome (FBSS). Subjects will be followed for a 6-month period after a maximum one-month trial period. At the end of 6 months follow-up, all subjects will assess the outcomes of their appointed therapy and continue with long-term use of the system. Stimulators will be placed at the following sites to target the painful area: • Epidural Space midline covering vertebrae levels T8 through T11 (one stimulator placed at the top of T8 and the second stimulator placed at the middle of T9). Paresthesia mapping will be utilised to determine the optimal location for stimulation of the painful area.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Freedom SCS System | This Freedom SCS System is based on wireless neuromodulation technology. This technology includes octapolar stimulators with embedded receivers. The energy source is a small, external, rechargeable transmitter, which is worn by the subject. The device is programmed to have a 5-1500 Hz therapy. |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2019-01-01
- Completion
- 2019-07-01
- First posted
- 2015-08-03
- Last updated
- 2021-10-06
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02514590. Inclusion in this directory is not an endorsement.