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Procedure

Spinal Cord Stimulation for Spinal Cord Injury (STIM Trial)

N/A

Recruiting

Led By Jared Wilcox, MD, PhD

Research Sponsored by H. Francis Farhadi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

An established diagnosis of either cervical myelopathy with modified Japanese Orthopaedic Association score of 8-14, or acute cervical/thoracic SCI with ASIA Impairment Scale grade A-D (as assessed within 72 hours of injury) with neurologic level of injury (NLI) from C2 to T12

Age: = 18 years and = 80 years

Must not have

Cardiac pacemaker dependent, unable to undergo electrical stimulation

mJOA of >= 15 and <= 7, or AIS grade E tSCI at baseline assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up twelve months

Awards & highlights

No Placebo-Only Group

Summary

"This trial will be a small study to test the safety and feasibility of a device called transcutaneous spinal cord stimulation. They plan to include 30 patients divided into 3 groups: those with non

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is a pilot study focusing on safety and feasibility, specific side effects aren't listed but may include discomfort at the stimulation site or skin irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a spinal cord injury or cervical myelopathy with a specific severity score.

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I am between 18 and 80 years old.

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I do not have any other life-threatening health conditions.

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I do not have sepsis.

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My surgery site is free from skin infections.

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I can have surgery or have already had it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I rely on a pacemaker and cannot have electrical stimulation.

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My spinal injury severity is moderate to severe, or I have no motor function loss.

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I am not part of another clinical trial or taking any experimental drugs that could affect this study.

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I experience heat or pain from my tattoo during electrical stimulation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ twelve months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~twelve months

This trial's timeline: 3 weeks for screening, Varies for treatment, and twelve months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ASIA Impairment Scale (ASIA / AIS)

Blood Pressure

GAITRite Walking Assessment

+9 more

Secondary study objectives

Adherence to Protocol

Adverse Event Rate

Data Collection and Monitoring

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Traumatic Spinal Cord Injury (tSCI) - Early/AcuteExperimental Treatment1 Intervention

Traumatic spinal cord injury (tSCI) screened during the hospital admission when cervical/thoracic spinal injury was diagnosed. 2-6 weeks after injury.

Group II: Non-Traumatic Spinal Cord Injury (ntSCI,) DCM - ProgressiveExperimental Treatment1 Intervention

Non-traumatic spinal cord injury (ntSCI) with diagnosis of degenerative cervical myelopathy (DCM) and offered surgical intervention. Prospective.

Group III: Traumatic Spinal Cord Injury (tSCI) - ChronicActive Control1 Intervention

Delayed traumatic spinal cord injury (tSCI) screened 6-24 months after acute cervical/thoracic spinal injury. The use of transcutaneous spinal cord stimulation (Tc-SCS) in chronic SCI delivered in the delayed timeframe is relatively well studied, and therefore will serve as the control arm.

0 / 10Eligibility criteria met