The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.
The researchers will conduct a traditional exploratory feasibility study using an investigational device to compare the clinical outcomes using time varying pulse (TVP) waveforms against time-invariant pulse (TIP) waveforms using both paresthesia and paresthesia-free SCS therapies. The therapy longevity of TVPs and TIPS will also be evaluated by tracking therapy efficacy through a long-term follow-up phase, using multiple pain assessments and at-home digital data collection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
43
Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.
Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.
Baylor College of Medicine
Houston, Texas, United States
RECRUITINGChange in Patient responder rate
The primary endpoint for this trial will be a comparison of the percentage of patients achieving at least a 50% reduction in pain during the TIP stimulation block with the percentage of patients achieving at least a 50% reduction in pain during either TVP stimulation block.
Time frame: Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.
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