BridgeMD
New treatment option for Spinal Cord Injuries
Official title Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord
ClinicalTrials.gov ID: NCT06225245
What this study is testing
- What it's testing
- The goal of this study is to investigate the effects of cervical epidural spinal stimulation with upper extremity training. This is an investigational study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65. Healthy volunteers may be eligible.
You may be able to join if
- All participants must provide a signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 22 - 65 years old.
- Must provide documentation from personal primary treating physician that reports stable medical condition.
- Able to passively range bilateral upper extremities within normal mobility parameters including:
You likely can't join if
- Currently involved in another rehabilitation training study.
- Lower motor neuron injury revealed in the upper limbs.
- Stabilization hardware in the cervical spine, preventing implantation of ESS system.
- Active pressure sores, wounds, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including contractures in...
- Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: ventilator dependence...
- Intrathecal baclofen pump therapy for spasticity.
See the full eligibility criteria
- All participants must provide a signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male or female aged 22 - 65 years old.
- Must provide documentation from personal primary treating physician that reports stable medical condition.
- Able to passively range bilateral upper extremities within normal mobility parameters including:
- greater than 90 degrees of shoulder flexion and 20 degrees of shoulder extension;
- greater than 120 degrees of elbow flexion and reach elbow extension of approximately 150 degrees;
- neutral wrist position reaching a minimum of 70 degrees of movement (between flexion and extension;
- ability to passively flex and extend fingers.
- Maintain current oral anti-spasticity regimen/dosage as approved by study physician with no change in regular use that may affect study outcomes.
- Six (6) months to 20 years post spinal cord injury.
- Non-progressive spinal cord injury.
- Chronic SCI with neurologic level of injury as defined by ISNCSCI AIS A, B, or C.
- Neurological level of injury above T2.
- Eligible for fMRI per safety questionnaire.
- Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study.
- Currently involved in another rehabilitation training study.
- Lower motor neuron injury revealed in the upper limbs.
- Stabilization hardware in the cervical spine, preventing implantation of ESS system.
- Active pressure sores, wounds, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including contractures in the upper and lower extremities).
- Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: ventilator dependence, cardiopulmonary disease, uncontrollable autonomic dysreflexia or...
- Intrathecal baclofen pump therapy for spasticity.
- Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months which would result in absence of muscle tone and thus preclude response to electrical stimulation therapy.
- Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse.
- Any reason the PI or treating physician may deem as harmful to the participant or inappropriate for the participant to enroll or continue in the study.
- Body Mass Index (BMI) over 30.
- Pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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, 22 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.