Comparison of 1000 Hertz (Hz), Burst, and Standard Spinal Cord Stimulation in Chronic Pain Relief

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Chronic Pain

In brief

A randomized controlled with cross over study compares efficacy of burst stimulation, 1000 hertz stimulation, and standard stimulation in an non-superiority trial. The study duration is approximately 24 weeks and each stimulation modes will last for approximately 3 weeks with approximately 4 days of wash off in between.

Key facts

Study ID

NCT02902796

Run by

The Center for Clinical Research, Winston-Salem, NC

People needed

20

Starts

2016-09-01

Expected to finish

2019-12-01

Last updated by the study team

2019-01-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject must be 18 years and older, and younger than 75 years of age.
• Subject has had a Precision Spectra, or Plus spinal cord stimulator system implanted for chronic painful condition.
• Subject continues to receive adequate pain relief with greater than or equal to 50% pain relief based on pre-trial and pre-implant pain assessment.
• Device age should not be less than 2 months old.
• Subject is willing to comply with all requirements of the study.

You may not qualify if…

• Subjects who are getting <50% pain relief on current SCS based on pre-trial and pre-implant pain assessment.
• Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
• Unstable medical or psychiatric illness
• Urine drug screen shows controlled substance/s not prescribed by the prescribers.
• 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.

Where it is running

• Jason Hong — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.