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Behavioural Intervention
Conventional SCS programming for Chronic Back Pain (NOVA Trial)
N/A
Waitlist Available
Research Sponsored by SGX Nova LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
NOVA Trial Summary
This trial will compare the effects of two types of spinal cord stimulation programming approaches in subjects with chronic, intractable pain.
Eligible Conditions
- Chronic Back Pain
NOVA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Subjects Who Respond to DTM-SCS Therapy Compared to Conventional SCS Therapy
NOVA Trial Design
2Treatment groups
Active Control
Group I: Conventional SCS programmingActive Control1 Intervention
This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Control treatments, which may identify the type of treatment to study participants. Conventional SCS programming is stimulation parameters in the 40-250 Hz frequency range and will be trialed according to standard practice as described in the Intellis labeling/manuals
Group II: DTM-SCS programmingActive Control1 Intervention
This SCS group will be programmed under the direction of physicians with support of clinical representatives of the Test treatments, which may identify the type of treatment to study participants. DTM-SCS programming has at least two programs with different pulse rate in the 50 to 1,000 Hz range and each having a maximum pulse width of 1 ms.
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Who is running the clinical trial?
SGX Nova LLCLead Sponsor
Ricardo Vallejo, MDStudy ChairSGX Medical
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently recruiting volunteers for this trial?
"This research project, which was first published on the 2nd of September 2020 and last changed in records on 26th September 2022, is currently not searching for participants. However, there are 283 other clinical trials actively recruiting at this time."
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