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New treatment option for Spinal Cord Injury (SCI)
Official title Implant for Walking After Incomplete SCI
ClinicalTrials.gov ID: NCT06965127
What this study is testing
- What it's testing
- This is a device study that will evaluate the effect of an implanted stimulator on improving walking in people with incomplete spinal cord injury. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes implanting the device and setting the individual up for system use, creating controllers for walking, and evaluating the effect of the device over a couple years.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Between the ages of 18-75
- Non-ventilator dependent paralysis resulting from injuries such as: cervical/thoracic spinal cord injuries affecting the trunk and/or lower limbs
- Impairment classification of AIS B, C, or D (preservation of sensation and/or some motor function) with weakness in trunk and/or lower extremity...
- Unable to walk faster than 0.8m/s during a 10m walk test
- Gait deviation such as reduced peak hip, knee, and/or ankle range of motion during stance or swing phases due to motor impairment
You likely can't join if
- Significant fracture risk or history of spontaneous fractures
- History of heterotopic ossification at the hip, knee, or ankle
- Non-English speaking
- Insufficient upper extremity function to use an assistive device (e.g. walker or cane)
- Females who are pregnant
- Current pressure injury that would be exacerbated by study activities
See the full eligibility criteria
- Between the ages of 18-75
- Non-ventilator dependent paralysis resulting from injuries such as: cervical/thoracic spinal cord injuries affecting the trunk and/or lower limbs
- Impairment classification of AIS B, C, or D (preservation of sensation and/or some motor function) with weakness in trunk and/or lower extremity muscles
- Unable to walk faster than 0.8m/s during a 10m walk test
- Gait deviation such as reduced peak hip, knee, and/or ankle range of motion during stance or swing phases due to motor impairment
- Time post injury greater than six months
- Innervated and excitable lower extremity and trunk musculature
- Adequate social support and stability
- Willingness to comply with follow-up procedures
- Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
- Neurologically stable as determined by a physician
- Significant fracture risk or history of spontaneous fractures
- History of heterotopic ossification at the hip, knee, or ankle
- Non-English speaking
- Insufficient upper extremity function to use an assistive device (e.g. walker or cane)
- Females who are pregnant
- Current pressure injury that would be exacerbated by study activities
- Uncontrolled spasticity that would interfere with study activities
- Significant range of motion limitations that would compromise study activities
- History of vestibular dysfunction, balance problems, or spontaneous falls
- Disorder or condition that require MRI monitoring
- Acute and/or untreated orthopedic issues that would prevent weight bearing or exercising implanted muscles such as a dislocation or fracture
- Acute and/or chronic medical problems left untreated or not controlled that would increase risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise
- Uncontrolled diabetes or hypertension
- Presence of a demand pacemaker, cardiac defibrillator, or neuroprosthesis system with components in the legs
- Any other medical or psychological condition that would be a contraindication Implant eligibility criteria
- In addition to all of the above, the participant must be able to fully support their body weight in standing with an assistive device prior to implantation.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.