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Device

Coordinated Reset spinal cord stimulation for Neuropathic Pain

N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients have pronounced pain, i.e. visual analog scale score (VAS) ≥6 and respond to conventional SCS, i.e. VAS reduction of at least 50% with SCS.
Patients with chronic neuropathic lower extremity pain, without back pain, who have consented to undergo or are undergoing spinal cord stimulation (SCS)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month
Awards & highlights

Study Summary

This trial is designed to study whether a new spinal cord stimulation paradigm, called Coordinate Reset (CR) Stimulation, can provide better pain relief with reduced energy requirements when compared to conventional stimulation. This study will also look at whether there are changes in brain function associated with effective CR stimulation.

Eligible Conditions
  • Neuropathic Pain
  • Back Surgery Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have severe pain with a score of 6 or more on a scale used to measure pain levels. You have tried conventional SCS (a type of electrical stimulation therapy) and it has reduced your pain by at least 50%.
Select...
You have long-term nerve pain in your legs but not in your back, and you are currently receiving or considering spinal cord stimulation treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month
This trial's timeline: 3 weeks for screening, Varies for treatment, and one month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain relief
Secondary outcome measures
Activity level
Electroencephalography (EEG)
Event Related Potentials (ERP)
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Coordinated Reset- Spinal Cord StimulationExperimental Treatment1 Intervention
All subjects will undergo spinal cord stimulation (SCS) implantation and will be optimized on standard SCS (sSCS) settings using the standard clinical protocol, including paresthesia mapping, threshold finding, and adjustment of stimulation parameters to provide reduction in pain. Therapeutic sSCS will be maintained for a minimum of one month prior to baseline assessment. Following a washout period of three hours assessments will be performed and Coordinated Reset- spinal cord stimulation (CR-SCS) will be enabled by means of a firmware upgrade. Personnel from Boston Scientific will perform this upgrade. The simulator will then be programmed to deliver CR-SCS. At the end of one month of CR-SCS (with stimulation parameters similarly held constant for the last 7 days), baseline assessment will be repeated after a three hour washout period. Finally, a firmware downgrade will be performed by Boston Scientific Personnel, and patients will be treated with sSCS at their previous settings.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,374 Previous Clinical Trials
17,332,927 Total Patients Enrolled
4 Trials studying Neuropathic Pain
535 Patients Enrolled for Neuropathic Pain

Media Library

Coordinated Reset spinal cord stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04997278 — N/A
Neuropathic Pain Research Study Groups: Coordinated Reset- Spinal Cord Stimulation
Neuropathic Pain Clinical Trial 2023: Coordinated Reset spinal cord stimulation Highlights & Side Effects. Trial Name: NCT04997278 — N/A
Coordinated Reset spinal cord stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04997278 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have registered to participate in the research?

"Correct. According to clinicaltrials.gov, this medical study is currently accepting new participants; the trial was first posted on July 12th 2021 and its details were most recently updated on July 25th 2022. The research requires 10 volunteers from a single site."

Answered by AI

Are individuals below the age of 25 permitted to partake in this experiment?

"According to the stipulated criteria, this trial is accepting participants between 22 and 70 years of age."

Answered by AI

Are there still opportunities for individuals to become part of this research endeavor?

"Affirmative. According to the data available on clinicaltrials.gov, this medical experiment is still accepting participants since its original posting date of July 12th 2021 and subsequent update on July 25th 2022. 10 volunteers are required from one location for enrollment in the trial."

Answered by AI

Could I potentially be a candidate for this medical examination?

"This clinical trial seeks 10 individuals between the ages of 22 and 70 who are currently suffering from failed back surgery syndrome. Furthermore, they must be able to fluently communicate in English, have chronic neuropathic lower extremity pain but no back pain, have had conventional spinal cord stimulation (SCS) for at least 3 months before beginning the study, demonstrate pronounced pain with a VAS score of 6 or higher that responds well to SCS treatment indicated by a 50% reduction on their VAS scale."

Answered by AI
~0 spots leftby Mar 2025