High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System

Completed · Phase 4

Conditions studied: Chronic Pain, Low Back Pain, Radiculopathy, Complex Regional Pain Syndrome (CRPS)

In brief

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 stimulator.

Key facts

Study ID

NCT02265848

Run by

The Center for Clinical Research, Winston-Salem, NC

People needed

22

Starts

2014-10-01

Expected to finish

2015-01-01

Last updated by the study team

2016-10-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Center for Clinical Research — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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