Trials / Completed
CompletedNCT03350256
BurstDR™ micrOdosing stimuLation in De-novo Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.
Detailed description
Microdosing BurstDR consists of periods during which stimulation is delivered with standard BurstDR stimulation parameters alternated with periods during which no stimulation is being delivered. In this study the investigators propose to evaluate therapeutic efficacy of BurstDR microdosing, and determine optimal microdosing programming parameters in chronic pain patients, who are eligible for SCS therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient. | BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients. |
Timeline
- Start date
- 2017-10-30
- Primary completion
- 2019-07-02
- Completion
- 2019-07-02
- First posted
- 2017-11-22
- Last updated
- 2020-03-19
- Results posted
- 2020-03-19
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03350256. Inclusion in this directory is not an endorsement.