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Procedure

SCS for Spinal Cord Injury

N/A
Recruiting
Led By Shivanand Lad, MD, PhD
Research Sponsored by Nandan Lad, M.D., Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have chronic pain (i.e., Pain >3 for > 3 months)
Subjects must be 18-80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 months
Awards & highlights

Study Summary

This trialstudies the impact of Spinal Cord Stimulation (SCS) with or without conventional medical management (CMM) on Spinal Cord Injury (SCI) pain and rehabilitation. Subjects receive SCS and/or CMM, with or without rehabilitation, and are followed up for 12 months.

Who is the study for?
This trial is for adults aged 18-80 with traumatic thoracic spinal cord injury and chronic pain, who can consent to the study and attend required visits. Candidates must be medically stable for SCS implant surgery and rehabilitation but cannot have complete cord transection, untreated major depression, active infection or substance abuse, or be pregnant.Check my eligibility
What is being tested?
The study compares Spinal Cord Stimulation (SCS) plus conventional medical management (CMM) against CMM alone in managing SCI pain and aiding rehabilitation. Participants will either receive SCS turned on or off randomly while continuing CMM like medications and physical therapy for a year.See study design
What are the potential side effects?
Potential side effects of SCS may include discomfort at the implant site, unwanted changes in bladder/bowel function or sensation, bleeding, infection risk from surgery, possible equipment failure, and varying responses to pain relief.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been in pain for more than 3 months.
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I am between 18 and 80 years old.
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I am medically fit for surgery and rehabilitation.
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I have a spinal cord injury in my chest area due to trauma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months 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
Motor recovery as measured by EMG
Motor recovery as measured by dynamometry
Secondary outcome measures
Change in Quality of Life (QOL) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29
Urinary Bladder
Spinal Cord
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EES onExperimental Treatment1 Intervention
Patients will undergo epidural electrical stimulation (EES) and be randomized in a 1:1 allocation to EES on. Both the patient and the provider will be formally blinded to treatment assignment. Only the biostatistician and programming team will be unblinded to treatment assignments.
Group II: EES offPlacebo Group1 Intervention
Patients will undergo epidural electrical stimulation (EES) and be randomized in a 1:1 allocation to EES off. Both the patient and the provider will be formally blinded to treatment assignment. Only the biostatistician and programming team will be unblinded to treatment assignments.ES off. Those in the EES off category will have their EES turned on at the 9-month timepoint.

Find a Location

Who is running the clinical trial?

Nandan Lad, M.D., Ph.D.Lead Sponsor
Shivanand Lad, MD, PhDPrincipal InvestigatorDuke University

Media Library

Spinal Cord Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04894734 — N/A
Spinal Cord Injury Research Study Groups: EES off, EES on
Spinal Cord Injury Clinical Trial 2023: Spinal Cord Stimulation Highlights & Side Effects. Trial Name: NCT04894734 — N/A
Spinal Cord Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04894734 — N/A

Frequently Asked Questions

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

Are there opportunities still available for participation in this clinical venture?

"According to public records on clinicaltrials.gov, this research is currently looking for participants with the study first being published September 15th 2022 and was most recently updated November 16th 2022."

Answered by AI

What demographic of people would be the ideal candidates for this clinical research?

"This clinical trial is looking to enrol a total of 30 participants, who must have contusions and fall within the specified age range (18-80)."

Answered by AI

Does this experiment accept participants aged fifty and over?

"This study is only open to patients aged between 18 and 80. Those below the age of consent have access to 146 other trials while those above 65 can choose from 790 different studies."

Answered by AI

Who else is applying?

What site did they apply to?
Duke University Health Systems
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)
Nandan Lad, M.D., Ph.D. 2021. "Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04894734.
All > Cervical Spondylotic Myelopathy
~7 spots leftby Dec 2024
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