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Transcutaneous Spinal Cord Stimulation + Activity-Based Therapy for Spinal Cord Injury (MACHINE Trial)

N/A
Recruiting
Led By Andrei Krassioukov, MD,PhD,FRCPC
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 2 and 14
Awards & highlights

MACHINE Trial Summary

This trial will investigate whether activity-based therapy (ABT), using a robotic exoskeleton, can change the strength of signals from the brain that control volitional movement, leading to improvements in standing and seated balance as well as other important involuntary bodily (i.e. cardiovascular, urinary tract, bowel and sexual) functions.

Eligible Conditions
  • Spinal Cord Injury
  • Neurogenic Bowel
  • Neurogenic Bladder

MACHINE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 2 and 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2 and 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in attempted voluntary motor activation (supine)
Change in attempted voluntary motor activation (walking)
Change in blood pressure regulation
+1 more
Secondary outcome measures
Change in bowel function measured by the NBDS
Change in cardiac structure and function
Change in corticospinal excitability
+14 more

MACHINE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ABT+TSCSExperimental Treatment2 Interventions
Therapeutic TSCS will be delivered during ABT using an isolated bipolar constant current stimulator. Continuous TSCS applied over the T11-T12 spinous processes at 5-40 Hz has been shown to induce stepping movements in participants with their legs in a gravity-independent position.
Group II: ABT+SHAMPlacebo Group2 Interventions
The SHAM is low-intensity, ineffective stimulation delivered at the same anatomical location as TSCS.

Find a Location

Who is running the clinical trial?

Praxis Spinal Cord InstituteUNKNOWN
3 Previous Clinical Trials
58 Total Patients Enrolled
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,467,004 Total Patients Enrolled
Andrei Krassioukov, MD,PhD,FRCPCPrincipal InvestigatorUniversity of British Columbia
4 Previous Clinical Trials
76 Total Patients Enrolled

Media Library

Activity-Based Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04726059 — N/A
Spinal Cord Injury Research Study Groups: ABT+SHAM, ABT+TSCS
Spinal Cord Injury Clinical Trial 2023: Activity-Based Therapy Highlights & Side Effects. Trial Name: NCT04726059 — N/A
Activity-Based Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04726059 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently enrolling in this research endeavor?

"Clinicaltrials.gov affirms that this clinical study is actively seeking participants, having been posted on May 26th 2022 and recently edited on the 24th of the same month."

Answered by AI

Am I eligible to enroll in this experimental program?

"This clinical trial requires potential participants to have neurogenic bowel and fall within the age bracket of 18-60. 12 individuals are currently being sought out for participation in this project."

Answered by AI

What are the targeted results of this clinical trial?

"This trial will primarily assess changes in voluntary contraction over the course of two weeks and fourteen days. Secondary targets include alterations to male sexual function recorded on an International Index of Erectile Function Questionnaire, dysautonomia measured via a 60-degree head-up tilt table test, and fluctuations in blood pressure variability monitored by 24 hour ambulatory BP monitors."

Answered by AI

How many participants is the maximum capacity for this experiment?

"Affirmative. According to information supplied by clinicaltrials.gov, this medical research is actively searching for 12 volunteers across 1 location. The trial was first posted on May 26th 2022 and the most recent update took place on May 24th 2022."

Answered by AI

Is this clinical investigation open to participants below the age of 45?

"This clinical trial is limited to adults aged 18-60."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Motor and Autonomic Concomitant Health Improvements With Neuromodulation and Exercise Training: A RCT in Individuals With SCI
Andrei Krassioukov 2022. "Motor and Autonomic Concomitant Health Improvements With Neuromodulation and Exercise Training: A RCT in Individuals With SCI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04726059.
~4 spots leftby Apr 2025
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