Actively Recruiting

Phase Not Applicable
Age: 19Years - 60Years
All Genders
ID05369520

Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury: Moving From Mechanisms to Clinical Practice

Led by University of British Columbia · Updated on 2025-12-08

30

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University of British Columbia

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the use of transcutaneous spinal cord stimulation (TCSCS) to improve autonomic functions that affect quality of life in people with spinal cord injury (SCI). This pilot clinical trial focuses on key autonomic problems like blood pressure regulation, bladder, bowel, and sexual dysfunction in adults with chronic SCI at or above the T6 spinal segment. The study is designed to explore how TCSCS may help reduce these dysfunctions and improve daily living. Participants will be randomly assigned to receive TCSCS using a non-invasive device (TESCoN or SCONE) targeting either the mid/low thoracic or lumbosacral spinal cord levels. The treatment lasts for 8 weeks with sessions three times per week. Before treatment, participants undergo mapping of spinal cord segments and baseline functional assessments with and without stimulation. After the 8-week treatment, further assessments are conducted over 4 weeks, and then repeated 8 weeks after stopping therapy to evaluate lasting effects. Throughout approximately 42 visits, participants will undergo various evaluations including blood pressure monitoring during tests such as head up tilt, digital anorectal stimulation, and urodynamic investigations. Additional tests include anorectal manometry, colonic motility assessment, cerebral blood flow measurements, and cognitive performance during stimulation. Researchers will track changes in these measures to assess TCSCS effects on autonomic functions and safety over time.

CONDITIONS

Brief Title

Non-invasive Spinal Cord Stimulation for Recovery of Autonomic Function After Spinal Cord Injury

Who Can Participate

Age: 19Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Resident of British Columbia, Canada with active provincial medical services plan.
  • Male or female, 19-60 years of age.
  • Chronic traumatic spinal cord injury (non-progressive, with complete motor paralysis) at or above the T6 spinal segment.
  • More than 1 year post injury and at least 6 months from any spinal surgery.
  • American Spinal Injury Association Impairment Scale (AIS) A or B.
  • Stable management of spinal cord related clinical issues such as spasticity.
  • Experience bladder, bowel, or sexual dysfunction.
  • No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or active infection that may interfere with testing.
  • For women of childbearing potential: negative pregnancy test before baseline, use of adequate contraception or abstinence during the trial and for 28 days after, stable hormonal contraception if used.
  • For sexually active males with female partners of childbearing potential: use adequate contraception or abstinence during the trial and for 28 days after.
  • Provide informed consent.
  • Willing and able to comply with all clinic visits and study procedures.
  • Able to understand and complete study questionnaires in English or with an interpreter.
Not Eligible

You will not qualify if you...

  • Ventilator dependent.
  • Signs of lower motor neuron damage (such as conus medullaris or cauda equina injury).
  • Severe anemia or low blood volume within the last six months.
  • History of cardiovascular, respiratory, bladder, or kidney disease unrelated to spinal cord injury, or presence of hydronephrosis or obstructive kidney stones.
  • History of seizures, epilepsy, or recurring headaches.
  • Clinically significant unmanaged depression or ongoing drug abuse.
  • Having an intrathecal baclofen pump.
  • Taking oral baclofen doses greater than 60 mg.
  • Received intradetrusor or intrasphincter botulinum toxin injections within six months before baseline.
  • Any implanted metal in the skull (except dental implants) or presence of pacemakers, stimulators, or medication pumps in the trunk.
  • Previous electrode implantation surgery.
  • Member of the investigational team or immediate family.
  • Severe acute medical issues or treatments that could affect study participation.
  • Known allergies to both blue dye and beetroot powder.
  • Known or suspected gastrointestinal obstruction.
  • Active inflammatory bowel disease or history of bowel perforation.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for screening and enrollment

Diagnostic Evaluation

Duration - 5 weeks

Participants undergo spatiotemporal mapping of spinal cord segments involved in autonomic functions followed by baseline functional assessments with and without stimulation.

7 visits over 5 weeks

Implementation

Duration - 8 weeks

Participants receive non-invasive transcutaneous spinal cord stimulation (TCSCS) at either mid/low thoracic or lumbosacral spinal cord levels, to improve autonomic function.

24 visits (3 times per week for 8 weeks)

Diagnostic Evaluation

Duration - 4 weeks

Participants undergo functional assessments to evaluate effects after completion of 8 weeks of stimulation.

5 visits over 4 weeks

Long-term Monitoring

Duration - Approximately 2 weeks

Participants are assessed to evaluate the persistent effects of stimulation 8 weeks after stopping therapy.

1 visit (in-person)

Trial Site Locations

Total: 2 locations

1

Blusson Spinal Cord Centre

Vancouver, British Columbia, Canada, V5Z 1M9

Actively Recruiting

2

St Paul's Hospital

Vancouver, British Columbia, Canada, V6Z 1Y6

Actively Recruiting

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Research Team

A

Andrea L. Maharaj, BSc

S

Soshi Samejima, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Non-invasive spinal cord neuromodulation enables volitional anti-gravity leg movements after motor-complete spinal cord injury: responders vs. non-responders.

Raza N Malik, Soshi Samejima, Alison M M Williams...

https://pubmed.ncbi.nlm.nih.gov/42152086