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NCT04894734 · ClinicalTrials.gov registry record · NA
Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)
A NA study of Spinal Cord Injury at T1-T12 Level and Traumatic Thoracic Spinal Cord Contusion, sponsored by Nandan Lad, M.D., Ph.D..
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04894734 is a NA study of Spinal Cord Injury at T1-T12 Level and Traumatic Thoracic Spinal Cord Contusion that is actively recruiting participants, run by Nandan Lad, M.D., Ph.D.. The registered enrollment target is 30 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04894734, a NA study of Spinal Cord Injury at T1-T12 Level and Traumatic Thoracic Spinal Cord Contusion, is actively recruiting participants, sponsored by Nandan Lad, M.D., Ph.D..
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this feasibility study is to compare the impact of Spinal cord stimulation \[SCS\] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 24 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy. 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 gro
Conditions Studied
Interventions
- DEVICE EES on
- DEVICE EES off
Study Locations (1)
North Carolina
- Duke University Health Systems - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-12-30 |
| Est. Completion | 2027-10-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04894734
The ClinicalTrials.gov registry entry for NCT04894734 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nandan Lad, M.D., Ph.D., which has 1 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Spinal Cord Injury at T1-T12 Level appearing as the primary indexed condition, and to 2 interventions - of which EES on is the first listed.
NCT04894734 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT04894734 about?
NCT04894734 is a clinical study titled "Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)". The purpose of this feasibility study is to compare the impact of Spinal cord stimulation \[SCS\] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participat...
What is the current status of trial NCT04894734?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2021-12-30. Estimated completion is 2027-10-31.
What conditions does trial NCT04894734 study?
This clinical trial studies the following conditions: Spinal Cord Injury at T1-T12 Level, Traumatic Thoracic Spinal Cord Contusion, Thoracic Spinal Cord Trauma, Traumatic Thoracic Spinal Cord Laceration, Post-Traumatic Thoracic Myelopathy.
What interventions are being tested in trial NCT04894734?
The interventions under investigation include: EES on (DEVICE), EES off (DEVICE).
Who is sponsoring clinical trial NCT04894734?
This trial is sponsored by Nandan Lad, M.D., Ph.D., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04894734 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Spinal Cord Injury at T1-T12 Level
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Traumatic Thoracic Spinal Cord Contusion
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North Carolina
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