Clinical Trial Name: SCONE “CONTINENCE” CLINICAL STUDY

Funding:

SpineX Inc.
 

Description

The new SCONE device delivers non-invasive electric stimulation through electrodes on the skin along the spine and over the hips to stimulate the spinal cord. It modulates the central nervous system directly via the spinal cord. SCONE is a technique that enables electrical stimulation of the spinal cord without the need for insertion or surgical implantation of stimulating electrodes to improve bladder function.

Living with MS may cause bladder dysfunction, like urinary incontinence and/or urgency which can limit everyday life. This study aims to evaluate the effectiveness and safety a new non-invasive of treatment in bladder dysfunction management that could improve quality of life and improve bladder symptoms. Participants should have MS, and have been diagnosed with Neurogenic Lower Urinary Tract Dysfunction (NLUTD)  more than 12 months ago.

Once eligible for the study, you will come in person for two treatments per week for 12 weeks. Each treatment visit is 60 minutes which consists of application of the non-invasive electrical stimulation on the back and over hips, while you are in a seated position. During the treatment, you are asked to stay seated in the lab, but can use computer, phone, or read, watch TV, etc.

Before and after the 12 weeks there will be an assessment visit where we conduct questionaries. During the study participants will be asked to cease medications taken to treat urinary storage symptoms of NLUTD (e.g., anticholinergics, Beta-3 agonists), although Alpha blockers (e.g., tamsulosin, alfuzosin) for urinary voiding symptoms are advised to be continued.

Please see more details on our recruitment site https://rally.massgeneralbrigham.org/study/scone