Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)
NCT ID: NCT04894734
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2021-12-30
2027-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Participating subjects will be allocated to one of two treatment groups:
1. Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation.
2. Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation \[SCS\]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation).
For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm.
At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 24 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary objective of this study is to to determine if neuromodulation can be used to augment pain relief and rehabilitation in spinal cord injury (SCI) in a real-world population while further characterizing neurophysiological measures and clinical outcomes.
The following data will be collected:
* Medical history and demographics
* Procedure characteristics
* Medications
* Visual Analog Scale (VAS) for pain intensity Guy/Farrar Patient Global Impression of Change (PGIC) scale ASIA motor and sensory scores and impairment grade
* QoL survey (PROMIS 29)
* Electromyography (EMG) / Nerve Conduction Studies (NCS)
* Spinal Cord Independence Measure (SCIM) survey
* Bladder control using standard clinical urodynamic studies
* For sleep, self-reported quality and average hours per night will be collected in a diary
* Programming parameters and characteristics
* Safety events (adverse events, device deficiencies, protocol deviations)
The outcome variables of interest will be collected and assessed across study visits. No pre-planned formal statistical hypothesis tests will be performed. Multivariable regression modeling and descriptive statistics will be utilized.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EES on
Patients will undergo epidural electrical stimulation (EES) and be allocated 1:1 to EES on.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments.
EES on
Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb.
EES off
Patients will undergo epidural electrical stimulation (EES) and allocated 1:1 to EES off.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments. Those in the EES off category will have their EES turned on at the 9-month time point.
EES off
Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
EES on
Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb.
EES off
Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Chronic neuropathic pain (i.e., Pain \>3 for \> 3 months)
3. Willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires
4. 18-80 years of age
5. Medically stable enough to undergo surgical implantation of an SCS / participate in rehabilitation regimens
Exclusion Criteria
2. Persistent spinal instability or other injury preventing ability to participate
3. Active infection
4. Comorbid psychosis or psychotic disorder
5. Untreated, clinically significant depression
6. Active drug or alcohol abuse
7. Pregnant women or women who intend to become pregnant during the duration of the study. Women of childbearing potential need a negative pregnancy test
8. Patients without symptoms of neuropathic pain \>3/10 for \> 3 months
9. Patient deemed not medically stable for surgery
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nandan Lad, M.D., Ph.D.
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nandan Lad, M.D., Ph.D.
Professor of Neurosurgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shivanand Lad, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Duke University Health Systems
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00106738
Identifier Type: -
Identifier Source: org_study_id