Coordinated Reset Spinal Cord Stimulation

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    10
  • sponsor
    Stanford University
Updated on 10 August 2022

Summary

The goal of this study is to evaluate whether a new spinal cord stimulation paradigm, called Coordinate Reset (CR) Stimulation, can provide equivalent or better pain relief with reduced energy requirements. The investigators will test this new stimulation paradigm in patients who are already undergoing spinal cord stimulation surgery. The investigators will also study whether there are changes in electroencephalography (brain waves) associated with this new stimulation paradigm.

The investigators hope to learn whether CR stimulation can provide equivalent or better pain relief with reduced energy requirements. They also hope to learn whether there are changes in brain function with effective CR stimulation compared to conventional stimulation.

This study will be testing a specific stimulation paradigm in people who have already consented to have spinal cord stimulation performed for treatment of their chronic pain.

Description

Study subjects will be identified from the pool of candidates for spinal cord stimulation (SCS) therapy at Stanford University. Subjects will have undergone a successful trial of Boston Scientific spinal cord stimulation and will either be candidates for permanent stimulator implantation, or will have already undergone implantation. Ten subjects will be recruited over a one year period.

Following informed consent, subjects will be assessed to assure that they meet the criteria for study entry. All subjects will undergo 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.

Baseline assessments will be conducted following discontinuation of SCS for 24 hours. This assessment battery includes a physical and neurological exam, visual analog scale (VAS) score, Oswestry Disability Index, SF-12 and Global Assessment of Functioning, as well as EEG recordings (spontaneous EEG recording + dedicated pain-related evoked response recording). Following this baseline assessment, sSCS will be delivered for one month. Stimulation parameters will be held constant for the last 7 days of this period. During this time, subjects will use the CamNtech Pro-Diary wrist-worn data entry system to rate their back pain, leg pain and overall pain (3 questions), 3 times per day (morning, afternoon evening). The Pro-Diary allows for configurable, portable data entry as well as actigraphy.

The full assessment battery will be repeated, and the stimulator deactivated.

Following a washout period of three hours, VAS and EEG recordings will be performed. CR-SCS will be enabled by means of a firmware upgrade. Personnel from Boston Scientific will perform this upgrade. The stimulator 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), the assessment battery will be repeated, and VAS and EEG recordings will again be performed 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.

Details
Condition Pain, Neuropathic, Failed Back Surgery Syndrome
Treatment Coordinated Reset spinal cord stimulation
Clinical Study IdentifierNCT04997278
SponsorStanford University
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with chronic neuropathic lower extremity pain, without back pain, who have consented to undergo or are undergoing spinal cord stimulation (SCS)
Age 22 to 70
Fluent in English and able to independently provide consent
Patients treated with conventional SCS for at least 3 months prior to commencement of study, either newly implanted or already implanted
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

Exclusion Criteria

Significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
Current drug or alcohol abuse as determined by the investigator
Any history of recurrent or unprovoked seizures
Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months
Females who are pregnant, breastfeeding, or are of childbearing potential and planning to get pregnant during the course of the study or not using adequate contraception
On anticoagulation therapy
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note