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New treatment option for Spinal Cord Injuries
Official title Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury
ClinicalTrials.gov ID: NCT06213012
What this study is testing
- What it's testing
- It has been demonstrated that the human lumbosacral spinal cord can be neuromodulated with epidural (ESS) and transcutaneous (TSS) spinal cord stimulation to enable recovery of standing and volitional control of the lower limbs after complete motor paralysis due to spinal cord injury (SCI). The work proposed herein will examine and identify distinct electrophysiological mechanisms underlying transcutaneous spinal stimulation (TSS) and epidural spinal stimulation (ESS) to define how these approaches determine the ability to maintain self-assisted standing after SCI.
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 75
You may be able to join if
- All participants must be able to provide a provision of 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 22-75 years old.
- Documentation from the participant's primary treating physician confirming a stable medical condition.
- Inability to maintain standing independently without external support due to SCI AIS A-C.
You likely can't join if
- Ability to maintain standing independently without external support.
- Currently involved in another rehabilitation training of the lower extremities.
- Active pressure sores, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including but not limited to...
- Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: cardiopulmonary disease...
- Intrathecal baclofen pump therapy for spasticity not compatible with 3T MRI.
- Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months, resulting in absence of muscle...
See the full eligibility criteria
Who can join
- All participants must be able to provide a provision of 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 22-75 years old.
- Documentation from the participant's primary treating physician confirming a stable medical condition.
- Inability to maintain standing independently without external support due to SCI AIS A-C.
- Ability to tolerate at least 15 minutes in an upright (supported) position.
- Able to self-transfer from the wheelchair and demonstrate active range of motion of bilateral upper extremities in gravity dependent plane.
- Able to passively range bilateral lower extremities within normal mobility parameters including:
- greater than 90 degrees of hip flexion and 165 degrees of hip extension;
- greater than 90 degrees of knee flexion and reach neutral knee extension of 180 degrees;
- neutral ankle position reaching a minimum of 90 degrees of dorsiflexion.
- Participants should be on a stable intrathecal baclofen or oral anti-spasticity regimen/dose for the period of the study unless advised otherwise by their physician.
- 1 to 30 years post spinal cord injury.
- Non-progressive spinal cord injury.
- Neurological level of injury below C4 and above T12 (excluding conus injury and/or indications of lower motor neuron injury).
- 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.
- Able to commit to the full study.
What rules you out
- Ability to maintain standing independently without external support.
- Currently involved in another rehabilitation training of the lower extremities.
- Active pressure sores, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including but not limited to contractures in the upper and lower extremities).
- Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension...
- Intrathecal baclofen pump therapy for spasticity not compatible with 3T MRI.
- Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months, resulting in absence of muscle tone and precluding 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, including heavy alcohol use.
- Any reason the PI or treating physician may deem as harmful to the participant to enroll or continue in the study.
- Body Mass Index (BMI) over 30.
- Pregnancy.
- Use a ventilator or diaphragmatic pacer.
- Participants with the following conditions will be excluded from TMS, but may take part in the overall study:
- Personal or first-degree family history of seizures or epilepsy.
- Metal in the head, except mouth implants.
- History of suicide attempts.
- History of intracranial lesions, increased intracranial pressure, or stroke.
- Current use of tricyclic anti-depressants, selective serotonin reuptake inhibitors (SSRIs), serotonin nor-epinephrine reuptake inhibitors (SNRIs), buproprion (Wellbutrin), or tramadol.
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 75 years. 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.