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

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

Conditions

• Neurogenic Bladder
• Spinal Cord Injuries (Complete and Incomplete)
• Stroke
• Multiple Sclerosis

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

Sponsors & Collaborators

• Rancho Los Amigos National Rehabilitation Center, Downey, California, United States

  collaborator UNKNOWN

• Atrium Health, Charlotte, North Carolina, United States

  collaborator UNKNOWN

• MedStar National Rehabilitation Network, Washington, District of Columbia, United States

  collaborator UNKNOWN

• University of California, San Diego, California United States

  collaborator UNKNOWN

• Craig Hospital, Englewood, Colorado, United States

  collaborator UNKNOWN

• Columbia University, New York City, New York, United States

  collaborator UNKNOWN

• Institute of Brain and Spine (IBS Hospital), New Delhi, India

  collaborator UNKNOWN

• International Collaboration On Repair Discoveries (ICORD), Vancouver, British Columbia, Canada

  collaborator UNKNOWN

• University of Miami, Miami, United States

  collaborator UNKNOWN

• Mayo Clinic, Rochester, Minnesota, United States

  collaborator UNKNOWN

• Shepherd Center, Atlanta, Georgia, United States

  collaborator UNKNOWN

• Spaulding Rehabilitation Hospital, Charlestown, Massachusetts, United States

  collaborator UNKNOWN

• SpineX Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-25

Primary Completion

2024-05-01

Completion

2024-05-01

FDA Device

Yes

Countries

• United States
• Canada
• India

Study Locations