Chronic Spinal Cord Injury
Conditions
Interventions
For all patients, the pads (three) of the investigational device will be applied to the injured area of the spinal cord injury for 30 minutes per session, at least twice a day (maximum 2 hours).
Sponsors
Suda Kota
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 16 years of age or older at the time of consent. 2. Patients who are at least 6 months post-injury. 3. Patients with a modified Frankel classification of A, B, or C. 4. Patients who have given written consent to participate in the study of their own free will (however, patients who have difficulty in writing may write on their own behalf, and for minors, the consent of the patient and his/her surrogate should be obtained).
Exclusion criteria
Exclusion criteria: 1. Patients with impaired consciousness 2. Patients with neurological, cerebrovascular, or musculoskeletal disease that may affect the evaluation of neurological symptoms 3. Patients diagnosed with malignant tumor 4. Patients whose symptoms are expected to deteriorate rapidly during the treatment period 5. Patients with dementia or psychiatric disorders 6. Patients with multiple traumatic injuries or organ damage and unstable general condition 7. Patients with fractures of the extremities, spine, or other parts of the body that may affect the evaluation 8. Patients using life-supporting medical electrical equipment such as artificial heart lungs and pacemakers 9. Patients using medical electrical equipment such as electrocardiographs or other wearable medical devices 10. Patients with a history of substance abuse (e.g., alcohol) 11. Patients who are participating or have participated within 12 weeks prior to obtaining consent in clinical trials of other drugs or medical devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - ISNCSI:ASIA score (Motor, Sensory, Impairment scale) - Modified Frankel score - Neurological level of injury - Spinal Cord Independence Measure (SCIM-III) - Imaging findings - Adverse events, Disease etc. | — |
Contacts
Public ContactKota Suda
Hokkaido Spinal Cord Injury Center
Outcome results
None listed