Transcutaneous Spinal Cord Stimulation Home Study
Eligible age
19–70 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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
Sponsor: Michael Berger
You may qualify if…
- ✓ A participant must meet all of the following criteria in order to be eligible for inclusion:
- ✓ 1. Resident of British Columbia, Canada with active provincial medical services plan
- ✓ 2. Male or female, 19-70 years of age The safety and feasibility of home-based non-invasive spinal cord stimulation for orthostatic hypotension in individuals with severe autonomic dysfunctions (H23-00192) Protocol Version 1.0, December 8, 2023 Page 6 of 23
- ✓ 3. Chronic spinal cord injury (SCI) (non-progressive, with complete motor paralysis) at or above the T6 spinal segment OR Multiple System Atrophy (MSA) of the parkinsonian type.
- ✓ 4. \>1-year post injury or diagnosis, at least 6 months from any spinal surgery.
- ✓ 5. American Spinal Injury Association Impairment Scale (AIS) A, B for SCI or having OH (Orthostatic Hypotension) for MSA.
- ✓ 6. Willing and able to comply with all clinic visits and study-related procedures.
- ✓ 7. Able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator).
You may not qualify if…
- ✕ A participant who meets any of the following criteria will be ineligible to participate:
- ✕ 1. Ventilator dependent.
- ✕ 2. Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse.
- ✕ 3. Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study.
- ✕ 4. Intrathecal baclofen pump.
- ✕ 5. Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury (SCI) or presence of hydronephrosis or presence of obstructive renal stones.
- ✕ 6. Presence of severe acute medical issue that in the investigator's judgement would adversely affect the participant's participation in the study. Examples include, but are not limited to acute urinary tract infections, active heterotopic ossification, newly changed antidepressant medications \[tricyclics\], debilitating muscle pain, pressure sores, or unstable diabetes.
- ✕ 7. Any implanted metal (other than dental implants) in the skull or presence of pacemakers, stimulators, or medication pumps in the trunk.
Source: ClinicalTrials.gov · NCT06838637 · last updated 2025-02-20