N/A
N=6
Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI
Paraplegia · Tetraplegia · Paralysis · Quadraplegia
Bottom Line
View on ClinicalTrials.gov: NCT05095454 ↗Enrolled (actual)
6
Serious AEs
16.7%
Results posted
Jul 2024
Primary outcome: Primary: Electromyography — 0.00017507; 0.00006740 volts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Percutaneous epidural electrical spinal stimulation (Device); Transcutaneous electrical spinal stimulation (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Kristin Zhao, PhD
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Electromyography |
0.00017507; 0.00006740 | — |
| PRIMARY Foot Pressure |
6; 0; 40; 0 | — |
| PRIMARY Somatosensory Evoked Potentials |
0.67; 0.8; 0.33; 0.35 | — |
| PRIMARY Transcranial Magnetic Stimulation Motor Evoked Potentials |
3.33; 5 | — |
| PRIMARY Injury Severity: International Standards for Neurological Classification of Spinal Cord Injury |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Patient-reported Bowel Function |
-4; -3.5 | — |
| PRIMARY Patient-reported Bladder Function |
-11.3; -4.5 | — |
| PRIMARY Male Patient-reported Sexual Function (1) |
-6.3; 0 | — |
| PRIMARY Male Patient-reported Sexual Function (2) |
-23.3; -1.5 | — |
| PRIMARY Female Patient-reported Sexual Function |
— | — |
| PRIMARY Spasticity |
0.057; 0.088 | — |
| PRIMARY Neurostimulation User Experience |
3; 2.5; 1.5; 1.917; 2.583; 2 | — |
| PRIMARY Overground Ambulation [as Appropriate to the Subject] |
9.2; 16.5; 16.5 | — |
| PRIMARY Trunk Stability |
14.933333; 3; 34.933333; 21.5 | — |
| PRIMARY Neurostimulator Lead Location and Migration [Epidural Group Only] |
-5.35862 | — |
| PRIMARY Bladder Function Testing |
21; 10.5; 54.666667; 15 | — |
Summary
A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.
Eligibility Criteria
Inclusion Criteria
- Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae (T10)
- American Spinal Injury Association grading scale of A-D (2 from each) below the level of SCI
- Intact spinal reflexes below the level of SCI
- At least 1-year post-SCI
- At least 22 years of age
- Willing to use medically acceptable methods of contraception, if female and of child-bearing potential
Exclusion Criteria
- Currently a prison inmate, or awaiting trial, related to criminal activity
- Pregnancy at the time of enrollment
- History of chronic and/or treatment resistant urinary tract infection
- Unhealed decubitus ulcer
- Unhealed skeletal fracture
- Untreated clinical diagnosis of depression
- Undergoing, or planning to undergo, diathermy treatment
- Active participation in another interventional clinical trial
- Presence of conditions or disorders which require MRI monitoring
- A history of coagulopathy or other significant cardiac or medical risk factors for surgery
- Current use of a ventilator
- Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
- History of frequent hypotension characterized by light headedness, or loss of consciousness
- History of frequent hypertension characterized by headache, or bradycardia
- History of frequent, severe, autonomic dysreflexia
- Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
Data sourced from ClinicalTrials.gov (NCT05095454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.