Skip to navigation Skip to content
Menu

Navigation

National Multiple Sclerosis Society

Sign In
In Your Area
DonateDonate
v
  • What Is MS?

    • Definition of MS
    • What Causes MS?
    • Who Gets MS?
    • Multiple Sclerosis FAQs
    • Types of MS
    • Related Conditions
  • Symptoms & Diagnosis

    • MS Symptoms
    • Diagnosing MS
    • Magnetic Resonance Imaging (MRI)
    • Cerebrospinal Fluid (CSF)
    • Possible MS
    • Clinically Isolated Syndrome (CIS)
    • Newly Diagnosed
    • Other Conditions to Rule Out
    • For Clinicians
  • Treating MS

    • Comprehensive Care
    • Find Doctors & Resources
    • Medications
    • Managing Relapses
    • Rehabilitation
    • Complementary & Alternative Medicines
    • For Clinicians
  • Resources & Support

    • Library & Education Programs
    • Find Support
    • Advanced Care Needs
    • Resources for Specific Populations
    • Find Programs & Services in Your Area
    • Calendar of Programs and Events
    • Find Doctors & Resources
  • Living Well with MS

    • Diet, Exercise & Healthy Behaviors
    • Emotional Well-Being
    • Spiritual Well-Being
    • Cognitive Health
    • Work, Home & Leisure
    • Relationships
  • Research

    • Participate in Research Studies
    • Research News & Progress
    • Research We Fund
    • For Researchers
  • Get Involved

    • Fundraising Events
    • Volunteer
    • Advocate for Change
    • Raise Awareness
    • Join the Community
    • Stay Informed
    • Corporate Support
    • Personal Stories
  • d What Is MS?
    • d Definition of MS
      • Myelin
      • Immune-Mediated Disease
    • d What Causes MS?
      • Viruses
      • Clusters
    • d Who Gets MS?
      • Pediatric MS
      • African Americans
      • Hispanics & Latinos
    • d Multiple Sclerosis FAQs
    • d Types of MS
      • Clinically Isolated Syndrome (CIS)
      • Relapsing-remitting MS (RRMS)
      • Secondary progressive MS (SPMS)
      • Primary progressive MS (PPMS)
    • d Related Conditions
      • Acute Disseminated Encephalomyelitis (ADEM)
      • Balo’s Disease
      • HTLV-I Associated Myelopathy (HAM)
      • Neuromyelitis Optica (NMO)
      • Schilder's Disease
      • Transverse Myelitis
  • d Symptoms & Diagnosis
    • d Diagnosing MS
    • d Magnetic Resonance Imaging (MRI)
    • d Cerebrospinal Fluid (CSF)
    • d Possible MS
    • d Clinically Isolated Syndrome (CIS)
    • d Newly Diagnosed
    • d Other Conditions to Rule Out
      • Lyme Disease
      • Lupus
      • Neuromyelitis Optica
      • Acute Disseminated Encephalomyelitis (ADEM)
    • d For Clinicians
  • d Treating MS
    • d Comprehensive Care
      • Developing a Healthcare Team
      • Make the Most of Your Healthcare Provider Visits
      • Advance Medical Directives
    • d Find Doctors & Resources
    • d Medications
      • Adherence
      • Patient Assistance Programs
      • Meds Used Off Label
      • Make Medications Accessible
      • Generic and Biosimilar - Medications
    • d Managing Relapses
      • Plasmapheresis
    • d Rehabilitation
      • Functional Electrical Stimulation (FES)
    • d Complementary & Alternative Medicines
      • Chiropractic Therapy
      • Marijuana
      • Massage and Bodywork
      • Acupuncture
      • Low-Dose Naltrexone
    • d For Clinicians
  • d Resources & Support
    • d Library & Education Programs
      • Webinar Series
      • Momentum Magazine
      • Educational Videos
      • Knowledge Is Power
      • Pathways to a Cure
      • Live Fully, Live Well
      • Everyday Matters
      • Free From Falls
      • Relationship Matters
      • Resilience: Addressing the Challenges of MS
      • Webcasts
      • DVDs
      • Books
      • For Kids: Keep S'myelin
      • Información en Español
      • Brochures
    • d Find Support
      • Ask an MS Navigator
      • Community at MSconnection.org
      • Join a Local Support Group
      • Peer Connections: One-on-One
      • Edward M. Dowd Personal Advocate Program
    • d Advanced Care Needs
      • Pressure Sores
      • Osteoporosis
      • Seeking Services: Questions to Ask
    • d Resources for Specific Populations
      • Pediatric MS Support
      • Veterans with Multiple Sclerosis
    • d Find Programs & Services in Your Area
    • d Calendar of Programs and Events
    • d Find Doctors & Resources
  • d Living Well with MS
    • d Diet, Exercise & Healthy Behaviors
      • Diet & Nutrition
      • Exercise
      • Heat & Temperature Sensitivity
      • Sleep
      • Vaccinations
      • Women's Health
      • Unhealthy Habits
      • Managing MS and Another Condition
      • Aging with MS
      • Anesthesia and Surgery
      • Managing Your MS
    • d Emotional Well-Being
      • Mood Changes
    • d Spiritual Well-Being
      • Building Spirituality into Your Life
    • d Cognitive Health
    • d Work, Home & Leisure
      • Employment
      • Insurance & Financial Information
      • Staying Mobile
      • Reclaiming Control
      • Accessibility
      • Technology
      • Recreation
      • Travel
      • Emergencies & Disasters
    • d Relationships
      • Disclosure
      • Family Matters
      • Parenting
      • Intimacy
      • Preventing Abuse
  • d Research
    • d Participate in Research Studies
      • Participate in a Clinical Trial
      • Surveys and Other Research Studies
      • Participate in Genetic Studies
      • Donate to Tissue Banks
    • d Research News & Progress
      • Research News
      • Stem Cells in MS
      • Progressive MS Research
      • Clinical Trials in MS
      • Wellness and Lifestyle Research
      • Diet
      • Vitamin D
      • How and Why Do Scientists Share Results
    • d Research We Fund
      • Stopping MS In Its Tracks
      • Restoring What's Been Lost
      • Ending the Disease Forever
      • How We Fund Research
      • FAQs about Society Research
      • Past Research Efforts
      • Driving Solutions
    • d For Researchers
  • d Get Involved
    • d Volunteer
      • Volunteer Information
      • Volunteer Recognition
    • d Advocate for Change
      • Become an MS Activist
      • Take Action
      • Current Advocacy Issues
      • Advocacy Results
      • Advocacy News
    • d Raise Awareness
    • d Join the Community
    • d Stay Informed
    • d Corporate Support
      • Corporate Partners
      • National Teams
      • Partnership Opportunities
    • d Personal Stories
      • Life with MS
      • Givers
      • Shakers
      • Families with MS
      • Seekers
      • Movers
      • Tributes
  • d Donate
    • d Support an Event Participant
    • d Donate Online
    • d Give in Honor or Memory
    • d Workplace Giving
    • d Employer Matching Gifts
    • d Gifts of Stock or Securities
    • d Giving Circles
      • Golden Circle
      • Circle of Distinction
      • Lawry Circle
      • Circle of Influence
    • d Planned Giving
    • d Other Ways to Give
      • Donate by Mail or Phone
  • d About the Society
    • d Vision
      • Strategic Plan
      • Independent Review of Society's Research Programs
    • d Careers
    • d Leadership
      • Board of Directors
      • Senior Leadership Team
      • Founder Sylvia Lawry
    • d Cultural Values
    • d Financials
      • Annual Reports
      • Sources of Support
    • d News
    • d Press Room
      • Events at a Glance
      • MS the Disease
      • Public Service Announcements
      • In the News Archives
    • d MS Prevalence
      • MS Prevalence FAQs
    • d Charitable Ratings
    • d Corporate Support and Programs
  • d Helpful Links
    • d Información en Español
    • d Site Map
    • d Site Tour
    • d Contact Us
  • d For Professionals
    • d Researchers
      • Society Funding
      • Deadlines
      • Apply Online
      • Funding Policies and Procedures
      • Scientific Peer Reviewers
      • Resources for Researchers
    • d Professional Resource Center
      • About MS
      • Diagnosing MS
      • Managing MS
      • Resources for You and Your Practice
      • Publications for Clinicians
      • Publications for Your Patients
      • MS Navigator Program
      • Programs and Services for Your Patients
      • Contact Us
      • Clinical Fellows
    • d Careers in MS
      • Clinical Care
      • Research
      • Have you met?
  • d Our Healthcare Voice
HomeResearch   Participate in Research Studies   Participate in a Clinical Trial

Share this page

FacebookTwitterEmail

Participate in a Clinical Trial

Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

Clinical Trial Finder

Search Results

Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject is ≥ 18 and ≤ 70 years old (male subjects) or ≥ 18 and ≤ 75 years (female subjects) 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-B on the AIS scale OR.
  • - Chronic, spinal cord injury at C3 to L1 classified as ASIA C-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 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 of NLUTD 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/REB/EC-approved informed consent.

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 electromagnetic 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. 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, 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 comorbid 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. 22. Subject was enrolled after the maximum number of targeted subjects were randomized into the respective disease or UUI group.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05301335
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

SpineX Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Recruiting
Countries Canada, India, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Neurogenic Bladder, Spinal Cord Injuries (Complete and Incomplete), Stroke, Multiple Sclerosis
Arms & Interventions

Arms

Experimental: Therapeutic Arm

Sham Comparator: Sham Arm

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rancho Research Institute, Downey, California

Status

Recruiting

Address

Rancho Research Institute

Downey, California, 90242

Site Contact

Spencer Toledo

[email protected]

4082035061

UC San Diego Health Systems, San Diego, California

Status

Recruiting

Address

UC San Diego Health Systems

San Diego, California, 92093

Site Contact

Trisha Kanie

[email protected]

4082035061

Craig Hospital, Denver, Colorado

Status

Recruiting

Address

Craig Hospital

Denver, Colorado, 80113

Site Contact

Clare Morey

[email protected]

4082035061

Medstar National Rehab, Washington, District of Columbia

Status

Recruiting

Address

Medstar National Rehab

Washington, District of Columbia, 20010

Site Contact

Christopher Riegner

[email protected]

4082035061

Miami, Florida

Status

Recruiting

Address

University of Miami, Desai Sehti Urology Institute

Miami, Florida, 33136

Site Contact

Zoe Szczotka

[email protected]

4082035061

Shepherd Centre, Atlanta, Georgia

Status

Recruiting

Address

Shepherd Centre

Atlanta, Georgia, 30309

Site Contact

Cathy Furbish

[email protected]

4082035061

Cambridge, Massachusetts

Status

Recruiting

Address

Spaulding Rehabilitation Hospital Cambridge

Cambridge, Massachusetts, 02138

Site Contact

William Muter

[email protected]

4082035061

Mayo Clinic, St. Mary's Campus, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic, St. Mary's Campus

Rochester, Minnesota, 55902

Site Contact

Tyson Scrabeck

[email protected]

4082035061

New York, New York

Status

Recruiting

Address

Columbia University Irving Medical Centre

New York, New York, 10032

Site Contact

Mahveesh Chowdhurry

[email protected]

4082035061

Atrium Health, Charlotte, North Carolina

Status

Recruiting

Address

Atrium Health

Charlotte, North Carolina, 28208

Site Contact

Robbin Clark

[email protected]

4082035061

International Sites

ICORD Vancouver, Vancouver, British Colombia, Canada

Status

Recruiting

Address

ICORD Vancouver

Vancouver, British Colombia, V5Z 1M9

Site Contact

Jennifer Phan

[email protected]

4082035061

Insitute of Brain and Spine, New Delhi, India

Status

Recruiting

Address

Insitute of Brain and Spine

New Delhi, ,

Site Contact

Sachin Samuel

[email protected]

4082035061

Resources

Clinical Trials in MS


The latest clinical research in MS, including trials funded by the Society and trials in progressive MS.

Read more

Read more

NARCOMS Patient Registry

Register as a willing MS research participant to facilitate multicenter studies. Initiated by the Consortium of MS Centers.

Visit NARCOMS

Visit NARCOMS

Posting a Trial

If you would like us to post a study on these pages, please email [email protected] to find out what information you need to submit for review.

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

Colophon

 

Stay Informed

Join Us

Facebook Twitter Instagram LinkedIn YouTube MS Connection
  • About the Society
    • Vision
    • Careers
    • Leadership
    • Cultural Values
    • Financials
    • News
    • Press Room
    • MS Prevalence
    • Charitable Ratings
    • Corporate Support
  • Helpful Links
    • Donate
    • MSConnection Blog
    • Información en Español
    • Glossary
    • Legal Notice/Privacy Policy
    • Site Map
    • Site Tour
    • Contact Us
  • For Professionals
    • Researchers
    • Physicians
    • Nurses
    • Rehabilitation Professionals
    • Mental Health Professionals
    • Health and Wellness Professionals
  • What Is MS?
  • Symptoms & Diagnosis
  • Treating MS
  • Resources & Support
  • Living Well with MS
  • Research
  • Get Involved
Hidden Link