Clinical trial NCT04894734: Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)
Official title: The Feasibility of Epidural Electrical Stimulation (EES) for Improving Pain and Rehabilitation Outcomes in Patients with Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Traumatic Thoracic Spinal Cord Myelopathy
Keywords: Spinal Cord Injury
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 12 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 randomly assigned 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 12 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: This study is a prospective, single center study. Data will be collected at baseline, time of procedure (trial and permanent), trial phase, and at 1, 3, 6, 12 and 15 months post-implantation.

The primary objective of this study is to collect data on Neuromodulation to Augment Pain and Rehabilitation in Spinal Cord Injury (SCI), a real-world population while further characterizing neurophysiological measures and clinical outcomes.

The following data will be collected:

* Baseline characteristics and demographics
* Procedure characteristics
* Medications
* 10-point Numerical Rating Scales (NRS) 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
* Ashworth spasticity scale
* Bladder control using standard clinical urodynamic studies
* 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.

Eligibility criteria: Inclusion Criteria:

Subjects enrolled in this study must meet all of the following inclusion criteria (based on investigator judgement):

1. Traumatic, thoracic SCI
2. Chronic 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:

Subjects enrolled in this study must not meet any of the following exclusion criteria (based on investigator judgement):

1. Complete cord transection
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

Primary outcomes:
measure: Change in Multidimensional Pain Inventory (MPI)-SCI average activity score
timeFrame: Baseline, 9 months
measure: Motor recovery as measured by EMG
timeFrame: Up to 9 months
measure: Motor recovery as measured by dynamometry
timeFrame: Up to 9 months
Secondary outcomes:
measure: Change in pain as measured by 10-point Numeric Rating Scales (NRS)
timeFrame: Baseline, 9 months
measure: Change in Quality of Life (QOL) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29
timeFrame: Baseline, 9 months
measure: Change in the number of prescriptions written as measured by Electronic Health Record abstraction.
timeFrame: Baseline, 9 months
measure: Change in the number of opioid prescriptions filled as measured by Electronic Health Record abstraction.
timeFrame: Baseline, 9 months
measure: Change in the overall improvement as measured by Guy/Farrar Patient Global Impression of Change (PGIC) scale
timeFrame: Baseline, 9 months
measure: Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score
timeFrame: Baseline, 9 months
measure: Change in motor recovery as measured by the ASIA impairment grades
timeFrame: Baseline, 9 months
measure: Change in independence of activities of daily living (ADLs) as measured by the Spinal Cord Independence Measure (SCIM) survey
timeFrame: Baseline, 9 months
measure: Change in limb movement as measured by the Ashworth spasticity scale
timeFrame: Baseline, 9 months
measure: Change in bladder control using urodynamics
timeFrame: Baseline, 9 months
measure: Change in motor recovery as measured by Transcranial Magnetic Stimulation Motor Evoked Potentials (TMS MEPs)
timeFrame: Baseline, 9 months
measure: Change in sensory recovery as measured by Somatosensory Evoked Potentials (SSEPs)
timeFrame: Baseline, 9 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health Systems
state: North Carolina
Study officials:
affiliation: Duke University
name: Shivanand Lad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.