Home therapy using spinal cord stimulation for patients with spinal cord injuries and multiple system atrophy

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

This study is testing a home therapy using a spinal cord stimulation device to see if it helps people with spinal cord injuries or multiple system atrophy manage symptoms like low blood pressure and bowel issues.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 19 Years to 70 Years
• Sex: All
• Sponsor: University of British Columbia (other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT06838637 on ClinicalTrials.gov

What this trial studies

This pilot clinical trial aims to evaluate the safety and feasibility of a home-based therapy using transcutaneous spinal cord stimulation (SCONE) for individuals suffering from orthostatic hypotension and bowel dysfunction due to spinal cord injuries or multiple system atrophy. Participants will undergo initial assessments at the research center, followed by a two-week treatment period at the center and a six-week home therapy phase where they will use the SCONE device for one hour, twice daily. The study will conclude with post-treatment evaluations to assess the effectiveness of the therapy on autonomic and cardiac functions.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 19-70 with chronic spinal cord injuries at or above the T6 level or those diagnosed with multiple system atrophy of the parkinsonian type.

Not a fit: Patients with progressive spinal conditions or those who do not meet the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve the management of orthostatic hypotension and bowel dysfunction in affected patients.

How similar studies have performed: While the approach of home-based spinal cord stimulation is relatively novel, similar studies have shown promising results in managing autonomic dysfunctions.

Eligibility criteria

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.

Where this trial is running

Vancouver, British Columbia

• ICORD, Blusson Spinal Cord Centre — Vancouver, British Columbia, Canada (RECRUITING)

Study contacts

• Principal investigator: Michael J Berger, MD, FRCPC — The University of British Columbia
• Study coordinator: Andrea Maharaj, BSc

Conditions: Spinal Cord Injuries, Multiple System Atrophy, Parkinson Variant, Transcutaneous Spinal Cord Stimulation, SCONE, Orthostatic Hypotension, Bowel Dysfunction, Autonomic Dysfunction