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New treatment option for Spinal Cord Injuries (Complete and Incomplete)
Official title Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury
ClinicalTrials.gov ID: NCT07204184
What this study is testing
- What it's testing
- A well-established rehabilitation strategy for improvements of standing and walking ability in persons with spinal cord injury (SCI) is step training on a motorized treadmill with body weight support. A promising intervention is stimulation of the spinal cord through the skin (transspinal).
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 70
You may be able to join if
- Willingness to comply with all study procedures and availability for the duration of the study.
- Ability to understand the consent form and sign the consent form.
- In good general health as evidenced by medical history.
- Diagnosed with incomplete SCI (AIS B, C, D).
- Bone mineral density of the hip (proximal femur) T-score \<3.5 SD from age- and gender-matched normative data.
You likely can't join if
- Supraspinal lesions.
- Neuropathies of the peripheral nervous system.
- Significant degenerative neurological disorders of the spine or spinal cord.
- Diagnosed with AIS A.
- Presence of pressure sores.
- Advanced urinary tract infection.
See the full eligibility criteria
- Willingness to comply with all study procedures and availability for the duration of the study.
- Ability to understand the consent form and sign the consent form.
- In good general health as evidenced by medical history.
- Diagnosed with incomplete SCI (AIS B, C, D).
- Bone mineral density of the hip (proximal femur) T-score \<3.5 SD from age- and gender-matched normative data.
- Lesion above thoracic (T) 10 to ensure absent lower motoneuron lesion.
- The presence of soleus and FCR H-reflexes.
- Absent permanent ankle joint contractures prevent passive or active ankle movement because corticospinal and spinal excitability is based on the ankle angle. The ankle straps of the Lokomat also require flexible ankle...
- A diagnosis of first time SCI due to trauma, vascular, or orthopedic pathology.
- Time after SCI of more than 6 months.
- Stable medical condition without cardiopulmonary disease or cognitive impairment.
- Supraspinal lesions.
- Neuropathies of the peripheral nervous system.
- Significant degenerative neurological disorders of the spine or spinal cord.
- Diagnosed with AIS A.
- Presence of pressure sores.
- Advanced urinary tract infection.
- Neoplastic or vascular disorders of the spine or spinal cord.
- Participation in an ongoing research study or new rehabilitation program.
- Pregnant women or women who suspect they may be or may become pregnant will be excluded from participation because the risks of thoracolumbar stimulation to the fetus are unknown.
- People with cochlear implants, pacemakers, implanted infusion device, and/or implanted stimulators of any type and purpose will be excluded to avoid their malfunction due to stimulation.
The study team makes the final eligibility decision.
Where it's taking place
- Staten Island, New York, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Staten Island, New York, 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.