RecruitingNot ApplicableNCT06838637

Transcutaneous Spinal Cord Stimulation Home Study

The Safety and Feasibility of Home-based Non-invasive Spinal Cord Stimulation for Orthostatic Hypotension in Individuals with Severe Autonomic Dysfunctions


Sponsor

Michael Berger

Enrollment

6 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this pilot clinical trial is to examine the safety and feasibility of SCONE as home based therapy for orthostatic hypotension and bowel dysfunction in individuals with spinal cord injury or multiple system atrophy. The main aims of the study are: * To establish a safe protocol for home-based transcutaneous spinal cord stimulation therapy at the research centre * To test the safety and feasibility of home-based transcutaneous spinal cord stimulation therapy on orthostatic hypotension and bowel dysfunction Participation will last approximately 10 weeks (excluding screening period) and involves * Attending the study center to collect baseline evaluations and to plan where electrodes will be placed * A 2 week treatment period at the centre with 3 visits per week * A 6 week home based therapy period involving 1 hour treatments twice a day * Attending the study center to collect post-treatment evaluations


Eligibility

Min Age: 19 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable device that sends mild electrical pulses to the spine can help people with dangerously low blood pressure when they stand up (called orthostatic hypotension). Participants will use the device at home, making it easier to take part without frequent hospital visits. **You may be eligible if...** - You live in British Columbia, Canada and have a provincial health card - You are between 19 and 70 years old - You have a chronic spinal cord injury (with complete paralysis at or above the T6 level) OR Multiple System Atrophy (parkinsonian type) - It has been more than 1 year since your injury or diagnosis, and at least 6 months since any spinal surgery - You are not pregnant or planning to become pregnant **You may NOT be eligible if...** - You depend on a ventilator to breathe - You have an intrathecal baclofen pump - You have a pacemaker, stimulator, or implanted metal in your body (other than dental) - You have serious unrelated heart, lung, bladder, or kidney disease - You take more than 40 mg of Baclofen per day - You have severe anemia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESpinal COrd NEuromodulation ("SCONE") Device

A non-invasive electrical device that provides transcutaneous spinal cord stimulation (TSCS) to the spinal cord by electrodes connected to a battery-powered source.


Locations(1)

ICORD, Blusson Spinal Cord Centre

Vancouver, British Columbia, Canada

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NCT06838637


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