Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorAshwin Viswanathan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to provide informed consent
Age ≥ 22
Chronic pain of the trunk and/or limbs for at least 6 months
Baseline average daily overall pain score of >60 (on a scale of 0-100mm) on the Visual Analog Scale related to pain of the back and/or limbs
Disqualifiers
Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 100 on a 0-100mm visual analog scale, every day during the 7 days prior to Screening, based on patient recall
Pain originating from peripheral vascular disease
Active treatment for cancer in past 6 months
Involved in disability litigation
Trial design
Design model
Crossover
Treatments tested in this trial
Spinal Cord Stimulator
DeviceSpinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.
Spinal Cord Stimulator
DeviceSpinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.
Treatment groups
43 Participants
are divided into 2 treatment groupsGroup A: Time Invariant Pulse(TIP) StimulationActive comparator 1 intervention
Group B: Time Variant Pulse (TVP) StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change 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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ashwin Viswanathan
Lead sponsor
Baylor College of Medicine
Sponsor institution
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Boston Scientific Corporation
Collaborator
Source ClinicalTrials.gov