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

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

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Multiple System Atrophy, Parkinson Variant
• Intervention / Treatment: Device: Spinal COrd NEuromodulation ("SCONE") Device

Detailed Description

Visit 1 - Screening

Visit 2 - Baseline Assessments

Visit 3 - Baseline EMG Mapping of Spinal Cord Segments with transcutaneous spinal cord stimulation

Visits 4-9 - Transcutaneous spinal cord stimulation

HOME-BASED Therapy (6 weeks)

Visit 10 - Post-treatment Autonomic Function Assessments

Visit 11 - Post-treatment Cardiac Function Assessments

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Maharaj, BSc; Phone Number: 604-675-8856; Email: amaharaj@icord.org
• Study Contact Backup: Name: Andrei Krassioukov, MD, FRCPC; Phone Number: 604-675-8816; Email: krassioukov@icord.org

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Recruiting
      • ICORD, Blusson Spinal Cord Centre
      • Contact: Andrea Maharaj, BSc; Phone Number: 604-675-8856; Email: amaharaj@icord.org
      • Contact: Michael J Berger, MD, FRCPC; Phone Number: 604-675-8852; Email: Michael.Berger@vch.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA

• 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).
  8. No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
  9. Stable management of spinal cord related clinical issues (i.e., spasticity management).

  10. Women of childbearing potential must not be intending to become pregnant, currently pregnant, or lactating. The following conditions apply:

      10.1. Women of childbearing potential must have a confirmed negative pregnancy test prior to the baseline visit.

      10.2. Women of childbearing potential must agree to use adequate contraception during the period of the trial and for at least 28 days after completion of treatment. Effective contraception includes abstinence.

  11. Sexually active males with female partners of childbearing potential must agree to use effective contraception during the period of the trial and for at least 28 days after completion of treatment.
  12. Must provide informed consent.

EXCLUSION CRITERIA

• 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.
  8. Takes more than 40mg of Baclofen per day.
  9. Severe anemia (Hgb<8 g/dl or Hgb,80 g/L) or hypovolemia as measured by hematocrit via blood test in the last six months.
  10. Participant is a member of the investigational team or his/her immediate family.
  11. Participant has undergone electrode implantation surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous Spinal Cord Stimulation; Transcutaneous spinal cord stimulation (TSCS) will be delivered using a portable non-invasive spinal cord stimulator (SCONE, SpineX Inc., CA, USA).	Device: Spinal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure (SBP) changes in millimeters of mercury (mmHg) during TSCS	Changes in SBP measures will be used to establish the BP component of the safety protocol for home-based TSCS with the purpose to mitigate orthostatic hypotension (OH).	6 weeks
Blood pressure (BP) changes in millimeters of mercury (mmHg) in 24-hrs	BP changes will be used to test the safety and feasibility of home-based TSCS (6 weeks) for orthostatic tolerance and bowel function in daily activities. The primary safety and feasibility measures will be continuously measured BP with a wireless BP device (Caretaker Medical LLC, USA, Class II, Medical Device Licence 320275) with and without stimulation, skin condition, any adverse event reports related to the stimulation.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour BP measurement in millimeters of mercury (mmHg)	BP data (i.e., systolic BP) will be monitored and used as a secondary safety measure in relation to better understanding OH in the context of the time course of cardiovascular changes in 24-hours.	6 weeks
Cardiovascular monitoring in mmHg	Beat-by-beat oscillometric cardiovascular monitoring (i.e., mmHg) will be tracked and used as a secondary safety measure in relation to better understanding OH in the context of the time course of cardiovascular function during the mock home-based sessions.	6 weeks
Adverse events (i.e., abnormal electrocardiograph)	Adverse events (i.e., abnormal electrocardiograph) will be tracked and used as a secondary safety measure in relation to better understanding OH in the context of the time course of the frequency and type of adverse events that can occur during mock home-based sessions.	6 weeks

Collaborators and Investigators

• Sponsor: Michael Berger
• Collaborators: University of British Columbia; Vancouver Coastal Health Research Institute; Vancouver Coastal Health; Rick Hansen Foundation; International Collaboration on Repair Discoveries; SpineX Inc.
• Investigators: Principal Investigator: Michael J Berger, MD, FRCPC, The University of British Columbia; Study Director: Andrei Krassioukov, MD, FRCPC, The University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 17, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Orthostatic Hypotension; Transcutaneous Spinal Cord Stimulation; Autonomic Dysfunction; Bowel Dysfunction; SCONE
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Neurodegenerative Diseases; Movement Disorders; Trauma, Nervous System; Basal Ganglia Diseases; Spinal Cord Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Spinal Cord Injuries; Multiple System Atrophy; Shy-Drager Syndrome
• Other Study ID Numbers: H23-00192

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No