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Transformation of Dormant Spinal Networks to Mitigate Symptoms of Neurogenic Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05301335
Recruitment Status : Recruiting
First Posted : March 29, 2022
Last Update Posted : June 9, 2022
Sponsor:
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.

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

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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

Resource links provided by the National Library of Medicine


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




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



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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05301335


Contacts
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Contact: Parag Gad 4082035061 info@spinex.co

Locations
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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
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Responsible Party: SpineX Inc.
ClinicalTrials.gov Identifier: NCT05301335    
Other Study ID Numbers: SPNX-01
First Posted: March 29, 2022    Key Record Dates
Last Update Posted: June 9, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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