High Frequency Stimulation Trials in Patients With Precision Spinal Cord Stimulator System
Launched by THE CENTER FOR CLINICAL RESEARCH, WINSTON-SALEM, NC · Oct 13, 2014
Trial Information
Current as of May 17, 2025
Completed
Keywords
ClinConnect Summary
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 changes in efficacy, and preferability between high and low frequency stimulation program for the spinal cord stimulator (SCS) system.
The study is designed as 7 week study that can take up to 9 weeks per subject. 7 weeks are divided into 3 segments. First segment will be 3 weeks of spinal cord stimulation followed by second segment of wash off period, which will take 1 week (7 days), then the la...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Subject must be 18 years and older, and younger than 70 years of age.
- • 2. Subject has had a Precision® spinal cord stimulator system implanted for chronic painful condition.
- • 3. Subject pain scores \>5 on NPRS
- Exclusion Criteria:
- • 1. Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain
- • 2. Unstable medical or psychiatric illness
- • 3. Lifetime history of psychosis, hypomania, or mania.
- • 4. Epilepsy, or dementia
- • 5. Substance abuse in the last 6 months
- • 6. Pregnant or breastfeeding
- • 7. Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
- • 8. Treatment with investigational drug within 30 days of screening.
- • 9. Concomitant medication exclusions consisting of medications or herbal agents with central nervous system (CNS) effects with exception of episodic use of sedating antihistamines
About The Center For Clinical Research, Winston Salem, Nc
The Center for Clinical Research in Winston-Salem, NC, is a leading organization dedicated to advancing medical science through innovative clinical trials. With a focus on enhancing patient care and treatment options, the center collaborates with pharmaceutical companies, healthcare professionals, and regulatory agencies to conduct rigorous research studies. Committed to ethical practices and patient safety, the Center for Clinical Research leverages state-of-the-art facilities and a team of experienced professionals to facilitate the development of new therapies across various therapeutic areas, ultimately aiming to improve health outcomes and contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Winston Salem, North Carolina, United States
Patients applied
Trial Officials
James M North, MD
Principal Investigator
The Carolinas Pain Institute
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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