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Device
Spinal Cord Stimulation for Chronic Pain
N/A
Waitlist Available
Led By Ashwin Viswanathan, MD
Research Sponsored by Ashwin Viswanathan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stable pain-related medication regimen 4 weeks prior to the trial. No new pain medication will be added during the study period
Consumed an average total daily morphine equivalent of ≤200 mg during the 30 days prior to Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.
Awards & highlights
Study Summary
This trial looks at how well a new pain relief treatment (spinal cord stimulation) works compared to the current standard.
Who is the study for?
This trial is for adults over 22 with chronic pain in the trunk or limbs, lasting at least 6 months and scoring above a 6 on the pain scale. Participants must have tried multiple treatments without success, be stable on current medications, not had recent back surgery, and pass psychological screening. Women of childbearing age must use contraception. Exclusions include high surgical risk patients, those with cognitive impairments or certain medical conditions.Check my eligibility
What is being tested?
The study tests new spinal cord stimulation (SCS) patterns against standard SCS to see which better reduces chronic pain. Candidates will receive an implantable device that delivers electrical pulses to the spine, aiming to alleviate their discomfort by altering nerve activity.See study design
What are the potential side effects?
Potential side effects from Spinal Cord Stimulation can include discomfort at the implant site, unwanted changes in stimulation feeling over time, tingling sensations in other body areas than intended, infection risks from surgery and possible equipment malfunction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pain medication has not changed in the last 4 weeks and won't change during the study.
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I have taken 200 mg or less of pain medication daily for the last month.
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My back pain moderately to severely affects my daily activities.
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My daily pain score for trunk or limb pain is more than 6.
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I have had chronic pain in my body for at least 6 months.
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I am 22 years old or older.
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I have not had back surgery in the last 6 months.
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I have tried more than 3 treatments and 2 types of medications for my condition without success.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Patient responder rate
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Time Variant Pulse (TVP) StimulationExperimental Treatment1 Intervention
The time variant pulse (TVP) stimulation will serve as the experimental arm for this study. There are two ways of delivering TVP stimulation to the spinal cord. TVP stimulation can either vary in intensity or it can vary rate, referred to as intensity-modulated TVP or rate-modulated TVP, respectively.
Group II: Time Invariant Pulse(TIP) StimulationActive Control1 Intervention
The control arm for this study will be the Time Invariant Pulse stimulation which is used in standard of care Spinal Cord Stimulation therapy. TIP tonic stimulation is delivered with fixed amplitude, pulse width, and frequency parameters.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Cord Stimulator
2018
N/A
~30
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Who is running the clinical trial?
Ashwin ViswanathanLead Sponsor
Boston Scientific CorporationIndustry Sponsor
719 Previous Clinical Trials
933,355 Total Patients Enrolled
32 Trials studying Chronic Pain
65,126 Patients Enrolled for Chronic Pain
Ashwin Viswanathan, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
25 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a problem with using drugs or alcohol in the six months before the study starts.My back pain moderately to severely affects my daily activities.I have taken 200 mg or less of pain medication daily for the last month.My pain medication has not changed in the last 4 weeks and won't change during the study.My daily pain score for trunk or limb pain is more than 6.I often feel my pain is unbearable, rating it a 10 out of 10.I have a high surgical risk due to allergies to titanium or silicone, or I have an infection.I am pregnant or might become pregnant during the study.You have a medical condition that may need diathermy treatment.My pain comes from a blood vessel condition in my limbs.I have been treated for cancer within the last 6 months.I plan to avoid massages or treatments that involve sudden movements near the device implant area.I don't have any conditions that would worsen with implant surgery or by having an implant.I can use a wrist-worn biosensor and mobile app.I have had chronic pain in my body for at least 6 months.I am 22 years old or older.I have not had back surgery in the last 6 months.I agree to use birth control during the study.You have had a spinal cord stimulation trial or have an active implanted device.My immune system is weakened.Currently involved in a legal case related to disability.You have a very high body weight compared to your height.I have tried more than 3 treatments and 2 types of medications for my condition without success.You have an illness that doctors expect will cause death within the next 12 months.
Research Study Groups:
This trial has the following groups:- Group 1: Time Invariant Pulse(TIP) Stimulation
- Group 2: Time Variant Pulse (TVP) Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still slots available for participation in this experiment?
"The particulars of this trial, as per clinicaltrials.gov's records, indicate that it is not currently enrolling patients. This experiment was posted on January 1st 2024 and underwent its last revisions on July 27th 2023; nonetheless, there are 505 other studies actively looking for volunteers presently."
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