Transformation of Dormant Spinal Networks to Mitigate Symptoms of Neurogenic Bladder

• ClinicalTrials.gov Identifier: NCT05301335
• Recruitment Status: Recruiting
• First Posted: March 29, 2022
• Last Update Posted: June 9, 2022
• Sponsor: SpineX Inc.
• Collaborators: Rancho Los Amigos National Rehabilitation Center; Wake Forest University Health Sciences; MedStar National Rehabilitation Network; University of California, Irvine; University of California, San Diego; Craig Hospital; Columbia University
• Information provided by (Responsible Party): SpineX Inc.

Study Description

Brief Summary:

The purpose of this study is to evaluate the effectiveness and safety of SCONE neuromodulation therapy after 12 weeks of therapy in comparison to inactive sham control in improving symptoms of Neurogenic Lower Urinary Tract Dysfunction

Condition or disease	Intervention/treatment	Phase
Neurogenic Bladder; Spinal Cord Injuries; Stroke; Multiple Sclerosis	Device: SCONE	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The study is designed as a prospective, multicenter, single blind, two-arm randomized sham-controlled clinical study. Subjects will be randomized into a treatment arm and control (sham) arm in a 2:1 ratio.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Transformation of Dormant Spinal Networks to Mitigate Symptoms of Neurogenic Bladder
• Actual Study Start Date: May 25, 2022
• Estimated Primary Completion Date: April 1, 2024
• Estimated Study Completion Date: April 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Therapeutic Arm	Device: SCONE; The Spinal COrd NEuromodulation(SCONE) device delivers a sufficient electrical signal non-invasively to activate the neural structures of the spinal cord without cutaneous discomfort. Rather than relying on stimulation of peripheral nerves, SCONE modulates the CNS directly via the spinal cord. Importantly, SCONE is a technique that enables electrical stimulation of the spinal cord without the need for insertion or implantation of stimulating electrodes
Sham Comparator: Sham Arm	Device: SCONE; The Spinal COrd NEuromodulation(SCONE) device delivers a sufficient electrical signal non-invasively to activate the neural structures of the spinal cord without cutaneous discomfort. Rather than relying on stimulation of peripheral nerves, SCONE modulates the CNS directly via the spinal cord. Importantly, SCONE is a technique that enables electrical stimulation of the spinal cord without the need for insertion or implantation of stimulating electrodes

Outcome Measures

Primary Outcome Measures :

1. Neurogenic Bladder Symptom Score (NBSS) [ Time Frame: 12 weeks ]
   Lower score represents improvements

Secondary Outcome Measures :

1. Urge Urinary Incontinence Episodes [ Time Frame: 12 weeks ]
   Lowered scores represents improvement
2. Patient Global Improvement Index (PGI-I) [ Time Frame: 12 weeks ]
   Lowered scores represents improvement

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Subject is ≥ 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 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 must demonstrate detrusor overactivity (unintentional detrusor contraction > 10 cm H2O) on clinical urodynamic studies.
5. Subject has sterile urine or asymptomatic bacteriuria.
6. Subject's score is > 28 on NBSS survey.
7. Subject is at least one year post initial diagnosis at the time of enrollment (consent).
8. Subject's medical condition is stable.
9. 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.
10. 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:

1. Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage.
2. Subject relies on an indwelling catheter (urethral or suprapubic) for bladder drainage.
3. Subject has participated in other transcutaneous or epidural spinal stimulation trials.
4. 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).
5. Subject has a concurrent neurological disease affecting the central nervous system, other than spinal cord injury or multiple sclerosis or stroke.
6. Subject has an implanted central or peripheral neuromodulator.
7. Subject has symptomatic, clinically significant autonomic dysreflexia attacks (characterized by headache and systolic blood pressure greater than 180 mmHg) more than once a week.
8. Subject is dependent on an electro-magnetic medical implant (e.g., cardiac pacemaker or implanted drug pump), ventilation support, or other external device.
9. Subject has received intravesical botulinum toxin injection within 12 months preceding enrollment.
10. Subject's BMI is > 35.
11. Subject has history of morphologic bladder outlet obstruction (e.g., due to benign prostatic hyperplasia, urethral stricture and/or bladder neck contracture).
12. 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.
13. 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.
14. For female subjects, history or physical exam consistent with > Stage II pelvic organ prolapse as defined by the International Continence Society.
15. For male subjects older than 55 years of age,13,14 physical exam or medical imaging (e.g., transrectal ultrasound, abdominal/pelvic computed tomography or magnetic resonance imaging) consistent with prostate size > 50 cm.
16. Subjects with significant stress incontinence as defined by > 3 stress incontinence episodes per day, defined as incontinence episodes precipitated by increased intraabdominal pressure (e.g., cough, sneeze, Valsalva maneuvers, transfers, other forms of physical activity), stress incontinence demonstrated on physical exam or abdominal leak point pressure < 100 cm H2O at bladder volume less than 200ml per urodynamics study.
17. Subject is pregnant or trying to become pregnant; or is nursing.
18. 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.
19. 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.
20. Subject has a medical condition not listed above that may put the subject at risk as determined by the Investigator.
21. Subject is participating in or plans to participate in another research study that may interfere with study endpoints.

22. Subject is known or suspected to be non-compliant; and/or subject is unable or unwilling to comply with study requirements.

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Contacts and Locations

Contacts

Contact: Parag Gad; 4082035061; info@spinex.co

Locations

United States, California

Rancho Research Institute; Recruiting

Downey, California, United States, 90242

Contact: Silvia Rodriguez silviar@ranchoresearch.org

Univ of California, San Diego; Recruiting

San Diego, California, United States, 92093

Contact: Jamie Finegan jlfinegan@health.ucsd.edu,

United States, Colorado

Craig Hospital; Recruiting

Denver, Colorado, United States, 80113

Contact: Clare Morey CMorey@craighospital.org

United States, District of Columbia

Medstar National Rehab; Recruiting

Washington, District of Columbia, United States, 20010

Contact: Inger Ljungberg Inger.H.Ljungberg@medstar.net

Sponsors and Collaborators

SpineX Inc.

Rancho Los Amigos National Rehabilitation Center

Wake Forest University Health Sciences

MedStar National Rehabilitation Network

University of California, Irvine

University of California, San Diego

Craig Hospital

Columbia University

More Information

• Responsible Party: SpineX Inc.
• ClinicalTrials.gov Identifier: NCT05301335
• Other Study ID Numbers: SPNX-01
• First Posted: March 29, 2022
• Last Update Posted: June 9, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Multiple Sclerosis; Spinal Cord Injuries; Urinary Bladder, Neurogenic; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Urinary Bladder Diseases; Urologic Diseases