Trials / Completed
CompletedNCT02896361
Burst Optimized Stimulation Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This purpose of this study is to evaluate the therapeutic efficacy of burst microdosing stimulation paradigms in patients with chronic pain.
Detailed description
This is a prospective, multicenter, randomized, double-blinded crossover study designed to compare conventional burst stimulation parameters to two different burst microdosing paradigms. Subjects will be randomized 1:1:1 to one of the three groups. Each group will evaluate all 3 stimulation paradigms in different order.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol | Stimulation parameters are reprogrammed from original values to study defined ones |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2017-08-01
- Completion
- 2017-08-01
- First posted
- 2016-09-12
- Last updated
- 2019-05-30
- Results posted
- 2019-05-20
Locations
3 sites across 2 countries: Belgium, Germany
Source: ClinicalTrials.gov record NCT02896361. Inclusion in this directory is not an endorsement.