30 Participants Needed

SCS for Spinal Cord Injury

AS
BP
Overseen ByBeth Perry, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nandan Lad, M.D., Ph.D.
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing Spinal Cord Stimulation (SCS) for patients with Spinal Cord Injury (SCI) to manage pain and improve physical functions. The treatment uses electrical pulses to interfere with pain signals and may help with movement and sensation. Patients will receive either active SCS treatment or their usual care. Spinal cord stimulation (SCS) has been used since 1967 and is an evidence-based treatment for various chronic pain disorders, including failed back surgery syndrome (FBSS).

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current medications. In fact, it mentions that all patients will continue receiving conventional medical management, which includes medications.

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) is generally considered a safe treatment for chronic pain conditions, with well-defined complication rates over 40 years of use. However, the risk of spinal cord injury during electrode implantation is not well understood, and the removal of paddle electrodes has risks that are not clearly defined in the literature.12345

How is the treatment Spinal Cord Stimulation (SCS) unique for spinal cord injury?

Spinal Cord Stimulation (SCS), particularly in its transcutaneous form (tSCS), is unique because it is a non-invasive treatment that uses electrical stimulation to activate spinal circuits and improve motor function in individuals with spinal cord injury. Unlike other treatments, it can enhance voluntary movement and muscle strength without surgery, making it a promising option for rehabilitation.26789

What data supports the effectiveness of the treatment Spinal Cord Stimulation, Epidural Electrical Stimulation (EES), Transcutaneous Spinal Cord Stimulation (tSCS) for spinal cord injury?

Research shows that transcutaneous spinal cord stimulation (tSCS) can help improve voluntary movement, muscle strength, and function in people with spinal cord injuries. Additionally, spinal cord epidural stimulation (scES) has enabled some patients to regain voluntary movement and even walk again after a spinal cord injury.267910

Who Is on the Research Team?

SL

Shivanand Lad, MD, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subjects must be willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires
I have been in pain for more than 3 months.
I am medically fit for surgery and rehabilitation.
See 1 more

Exclusion Criteria

Subjects must not have comorbid psychosis or psychotic disorder
Subjects must not have complete cord transection
Subjects must not have active drug or alcohol abuse
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Trial Procedure

Participants undergo a temporary trial procedure of SCS for 5-7 days to assess effectiveness

1 week
1 visit (in-person)

Treatment

Participants receive SCS ON or OFF along with CMM for 3 months. Placebo group may crossover to SCS ON after 3 months.

3 months
Multiple visits (in-person and remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at 1, 3, 6, 12, and 15 months post-implantation

9 months
Multiple visits (in-person and remote)

What Are the Treatments Tested in This Trial?

Interventions

  • Spinal Cord Stimulation
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EES onExperimental Treatment1 Intervention
Group II: EES offPlacebo Group1 Intervention

Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Spinal Cord Stimulation for:
🇪🇺
Approved in European Union as Spinal Cord Stimulation for:
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Approved in Canada as Spinal Cord Stimulation for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nandan Lad, M.D., Ph.D.

Lead Sponsor

Trials
1
Recruited
30+

Published Research Related to This Trial

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.
The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review.Taylor, C., McHugh, C., Mockler, D., et al.[2022]
Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.
Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.
Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis.de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]
In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).
Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.
Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury.Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

Citations

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]
Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]
Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]
Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]
Spinal cord epidural stimulation for motor and autonomic function recovery after chronic spinal cord injury: A case series and technical note. [2023]
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]
Incidence and avoidance of neurologic complications with paddle type spinal cord stimulation leads. [2022]
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]
Anticipating and preventing complications in spinal cord stimulator implantation. [2023]
Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]
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