30 Participants Needed

Spinal Cord Stimulation for Spinal Cord Injury

(STIM Trial)

KP
HF
Overseen ByH. Francis Farhadi, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The study will be a non-randomized, non-blinded pilot study to analyze the safety and feasibility of a non-significant risk device, transcutaneous spinal cord stimulation. The aim is to include 30 total patients, 10 patients in each of 3 groups:1. Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy and offered surgical intervention.2. Early tSCI screened during the hospital admission when cervical/thoracic spinal injury was diagnosed.3. Delayed tSCI (control) screened 6-24 months after acute cervical/thoracic spinal injury.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently involved in another study or receiving another interventional drug, you may not be eligible to participate.

Is transcutaneous spinal cord stimulation (tSCS) safe for humans?

Transcutaneous spinal cord stimulation (tSCS) is generally considered safe, with studies showing a low risk of complications. For example, a study on cervical spinal cord stimulation reported a 0.5% rate of spinal cord injury and low rates of other complications, indicating that the procedure is relatively safe for humans.12345

How is transcutaneous spinal cord stimulation (tSCS) different from other treatments for spinal cord injury?

Transcutaneous spinal cord stimulation (tSCS) is unique because it is a non-invasive treatment that uses electrodes placed on the skin to stimulate the spinal cord, promoting motor recovery and muscle activation without surgery. Unlike other treatments, tSCS can modulate spinal cord circuitry across multiple segments, potentially enhancing rehabilitation outcomes for individuals with spinal cord injury.36789

What data supports the effectiveness of the treatment Transcutaneous Spinal Cord Stimulation for spinal cord injury?

Research shows that Transcutaneous Spinal Cord Stimulation (tSCS) can help improve movement and muscle strength in people with spinal cord injuries by stimulating the spinal cord non-invasively. Studies have reported increased motor responses, such as voluntary movement and muscle activation, in both upper and lower limbs, suggesting it may be a promising therapy for enhancing motor function.367810

Who Is on the Research Team?

JW

Jared Wilcox, MD, PhD

Principal Investigator

University of Kentucky Neurosurgery

Are You a Good Fit for This Trial?

This trial is for people with spinal cord injuries, both traumatic and non-traumatic. It includes those recently diagnosed or injured up to 24 months ago, and patients with degenerative cervical myelopathy who are candidates for surgery.

Inclusion Criteria

I have a spinal cord injury or cervical myelopathy with a specific severity score.
Written informed consent by patient and/or legal authorized representative (LAR)
My surgery site is free from skin infections.
See 4 more

Exclusion Criteria

Any condition likely to result in the patient's death within the next 12 months
Unable to commit to the follow-up schedule
Pregnancy
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous spinal cord stimulation to evaluate safety and feasibility

12 months
Regular visits for stimulation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Follow-up assessments at established timepoints

Perioperative

Assessment of various functional measures during surgical intervention for ntSCI participants

Perioperative period

What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Spinal Cord Stimulation
Trial Overview The study tests the safety and practicality of using a device called Transcutaneous Spinal Cord Stimulation (Tc-SCS) on individuals with different types of spinal cord injuries in three separate groups.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Traumatic Spinal Cord Injury (tSCI) - Early/AcuteExperimental Treatment1 Intervention
Group II: Non-Traumatic Spinal Cord Injury (ntSCI,) DCM - ProgressiveExperimental Treatment1 Intervention
Group III: Traumatic Spinal Cord Injury (tSCI) - ChronicActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Francis Farhadi

Lead Sponsor

Trials
4
Recruited
410+

Francis Farhadi

Lead Sponsor

Trials
2
Recruited
330+

Published Research Related to This Trial

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 ฮฑ-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]
Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.
While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.
Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review.Megรญa Garcรญa, A., Serrano-Muรฑoz, D., Taylor, J., et al.[2021]
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]

Citations

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]
Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]
Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. [2022]
Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]
Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. [2022]
Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017]
Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]
Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. [2023]
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