Status:
COMPLETED
High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System
Lead Sponsor:
The Center for Clinical Research, Winston-Salem, NC
Conditions:
Chronic Pain
Low Back Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Study designed to compare the conventional stimulation programming versus the high frequency stimulation programming of the spinal cord stimulator for subjects who already have a spinal cord stimulato...
Detailed Description
Subject with Precision models of spinal cord stimulators will be invited to take part in the study that will compare the high frequency stimulation versus low frequency stimulation to look for any cha...
Eligibility Criteria
Inclusion
- Subject must be 18 years and older, and younger than 70 years of age.
- Subject has had a Precision® spinal cord stimulator system implanted for chronic painful condition.
- Subject pain scores \>5 on NPRS
Exclusion
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
- Unstable medical or psychiatric illness
- Lifetime history of psychosis, hypomania, or mania.
- Epilepsy, or dementia
- Substance abuse in the last 6 months
- Pregnant or breastfeeding
- Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
- Treatment with investigational drug within 30 days of screening.
- Concomitant medication exclusions consisting of medications or herbal agents with central nervous system (CNS) effects with exception of episodic use of sedating antihistamines
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02265848
Start Date
October 1 2014
End Date
January 1 2015
Last Update
October 25 2016
Active Locations (1)
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1
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103