Health Condition 1: G958- Other specified diseases of spinalcord
Conditions
Interventions
Intervention1: SpineX Spinal COrd NEuromodulation (“SCONE ?) Device: The SCONE (Spinal COrd NEuromodulation) device is a non-invasive CNS stimulator (electrical continence device) designed to provide
Sponsors
SpineX Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject between 18 and 70 years old at the time of enrollment/consent 2.Subject has a diagnosis of NLUTD due to: Chronic, spinal cord injury at C3 to T8 classified as ASIA A-D on the AIS scale (refer to Appendix 1: Abbreviations and Definitions); OR Multiple sclerosis; OR Stroke 3.Subject has symptoms of urinary urgency ( >50% high urge voids) or increased frequency of micturition/self - catheterization (more than once every 2 hours) or incontinence between voids or catheterizations ( >5/day). 4.Subject has sterile urine or asymptomatic bacteriuria. 5.Subject’s score is > 28 on NBSS survey. 6.Subject is at least one year post initial diagnosis at the time of enrollment (consent). 7.Subject’s medical condition is stable. 8.Subject has adequate social support network to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator. 9.Subject has been informed of the nature of the study, can understand the requirements of the study, agrees to participate, and has signed the IRB/EC-approved informed consent
Exclusion criteria
Exclusion criteria: 1. Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage. 2. Subject has a history of bladder augmentation or continent or incontinent urinary stoma or prior bladder surgery. 3. Subject has congestive heart failure, pulmonary disease necessitating supplemental oxygen use, chronic kidney disease (Stage III or higher), chronic liver disease (Child Pugh class B or C) or poorly controlled diabetes (if diabetic, HbA1c > 8.0 within the preceding 6 months). 4. Subject has a concurrent neurological disease affecting the central nervous system, other than spinal cord injury or multiple sclerosis or stroke. 5. Subject has an implanted central or peripheral neuromodulator. 6. Subject has symptomatic, clinically significant autonomic dysreflexia attacks (characterized by headache and systolic blood pressure greater than 180 mmHg) more than once a week. 7. Subject is dependent on an electro-magnetic medical implant (e.g., cardiac pacemaker or implanted drug pump), ventilation support, or other external device. 8. Subject has received intravesical botulinum toxin injection within 12 months preceding enrollment. 9. Subject’s BMI is > 35. 10. Subject has history of morphologic bladder outlet obstruction (e.g., due to benign prostatic hyperplasia, urethral stricture and/or bladder neck contracture). 11. Subject has history of frequent symptomatic urinary tract infections, defined as receiving five or more courses of urinary tract infection-directed antibiotics within 12 months prior to enrollment. SPNX-001 Version 2.0 Page 13 of 68 Confidential Exclusion Criteria (Cont.) 12. For non-catheterizing subjects, post-void residual is > 100 mL measured by bladder ultrasound, bladder scanner, or one-time catheterization at the time of enrollment. 13. For female subjects, history and/or screening responses consistent with pelvic organ prolapse. 14. For non-catheterizing male subjects older than 55 years of age, 13,14 screening responses consistent with benign prostatic hyperplasia. 15. Subjects with significant stress incontinence ( > 3 stress incontinence episodes per day), defined as incontinence episodes during physical activity such as cough, sneeze, transfers, and other forms of physical activity. 16. Subject is pregnant or trying to become pregnant; or is nursing. 17. Subject has limited life expectancy or co-morbid conditions, social/psychological problems, or cognitive impairments that, in the opinion of the Investigator, will preclude them from participation and completion of study procedures or requirements. 18. Subject has a medical condition or complications related to the use of certain medications that may affect validity of the study as determined by the Investigator. 19. Subject has a medical condition not listed above that may put the subject at risk as determined by the Investigator. 20. Subject is participating in or plans to participate in another research study that may interfere with study endpoints. 21. Subject is known or suspected to be non-compliant; and/or subject is unable or unwilling to comply with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NBSS Responder Rate (at least a 10-point reduction in NBSS score from Baseline to Final Evaluation)Timepoint: Screening (Day 0) Baseline : 7 to 9 days following the previous visit (if medication washout is required) 0 to 9 days following the previous visit(if no medication washout is required) Visit 1 : 5 to 7 days following the previous visit Visit 2 to Visit 24 : Within 3 ± 2 days of the previous session Visit 25: 5 to 7 days following visit 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| •Urge Urinary Incontinence (UUI) responder rate •Patient Global Improvement Index (PGI-I) responder rateTimepoint: Screening (Day 0) Baseline : 7 to 9 days following the previous visit (if medication washout is required) 0 to 9 days following the previous visit(if no medication washout is required) Visit 1 : 5 to 7 days following the previous visit Visit 2 to Visit 24 : Within 3 ± 2 days of the previous session Visit 25: 5 to 7 days following Visit 24 | — |
Countries
India
Contacts
Public ContactDr Sachin Kandhari
Institute of Brain & Spine
Outcome results
None listed