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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

Must not have

Patient exhibits catastrophization based on physician evaluation (e.g., average overall daily pain intensity of 10 on a 0-10 numerical rating scale, every day during the 7 days prior to Screening, based on patient recall)

A pregnant female or a female of childbearing potential planning to get pregnant during the course of the study

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

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I often feel my pain is unbearable, rating it a 10 out of 10.

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I am pregnant or might become pregnant during the study.

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My pain comes from a blood vessel condition in my limbs.

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I have been treated for cancer within the last 6 months.

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I plan to avoid massages or treatments that involve sudden movements near the device implant area.

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I don't have any conditions that would worsen with implant surgery or by having an implant.

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I can use a wrist-worn biosensor and mobile app.

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My immune system is weakened.

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Patient responder rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~230

0 / 16Eligibility criteria met