Epidural stimulation for improving function in chronic spinal cord injury patients
Monitoring the Effect of Epidural Stimulation on Sensorimotor and Autonomic Functions in Chronic Patients With Spinal Cord Injury
NA · University Hospital, Motol · NCT05690074
This study is testing whether epidural stimulation can help people with chronic spinal cord injuries regain control over their bodily functions and improve movement in their legs.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University Hospital, Motol (other) |
| Locations | 1 site (Prague) |
| Trial ID | NCT05690074 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of epidural stimulation (ES) in patients with chronic spinal cord injuries to regain autonomic control over cardiovascular, urinary, and sexual functions, as well as voluntary movement of the legs below the injury level. The intervention involves the use of the Spectra Wave Writer™ Spinal Cord Stimulator System. Researchers will also utilize functional magnetic resonance imaging to assess changes in brain activity before and after the stimulation. This approach seeks to provide a new therapeutic option for individuals with limited treatment options.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 with complete motor paralysis below T1 due to non-progressive spinal cord injuries sustained more than two years prior.
Not a fit: Patients who are ventilator-dependent or have significant comorbidities unrelated to spinal cord injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for patients with spinal cord injuries by restoring some level of voluntary movement and autonomic function.
How similar studies have performed: While the use of epidural stimulation in spinal cord injury is a relatively novel approach, preliminary studies have shown promising results in restoring some functions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * non-progressive SCI with complete motor paralysis below T1; American Spinal Injury Association Impairment Scale (AIS) A or B * 18 - 60 years of age; * longer than 2 years post injury; * stable medical condition * unable to voluntarily move all single joints of the legs; * spinal cort lesion between C7 and Th10 Exclusion Criteria: * ventilator dependent; * painful musculoskeletal dysfunction, unhealed fracture, contracture, or pressure sore that might interfere with training; * clinically significant depression or ongoing drug abuse; * cardiovascular, respiratory, bladder, or renal disease unrelated to SCI; * severe anemia (Hgb\<8 g/dl) or hypovolemia; and HIV or AIDS related illness.
Where this trial is running
Prague
- UH Motol — Prague, Czechia (RECRUITING)
Study contacts
- Study coordinator: Vojtech Rybka, Dr.
- Email: vojtech.rybka@fnmotol.cz
- Phone: +420224439253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spinal Cord Injuries, spinal cord injury, spinal cord stimulation, volitional movement, functional magnetic resonance imaging, autonomic nervous system