Status:
COMPLETED
Direct Comparison of Spinal Cord Stimulator Parameter Settings
Lead Sponsor:
Case Western Reserve University
Conditions:
Spinal Cord Stimulation
High-frequency Stimulation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
(Primary) 1. To compare the clinical effects and side effects of two different stimulation strategies that do not produce any sensory percept (1000 Hz and placebo) on clinical benefit for electrodes ...
Detailed Description
This is a prospective, randomized, double-blind study of different stimulation patterns in patients undergoing implantation of neurostimulator systems for chronic medically intractable neuropathic pai...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Diagnosis of chronic neuropathic pain for which placement of electrodes into the spinal column is planned for clinical indications (failed back surgery syndrome, peripheral neuropathy or complex regional pain syndrome)
- History of implantation of spinal cord stimulation system with rechargeable implanted neurostimulator
Exclusion
- Significant dementia or other condition preventing informed consent by the patient.
- Current drug or alcohol abuse or dependence.
- Uncontrolled depression or anxiety or failure to pass psychological screening for spinal cord stimulation.
- Inability or unwillingness to cooperate with clinical testing.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT05283863
Start Date
June 1 2015
End Date
August 1 2015
Last Update
May 21 2024
Active Locations (1)
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1
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44122