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Non-Invasive Neuromodulation for Spinal Cord Injury (RISES-T2 Trial)
N/A
Waitlist Available
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once at 2 weeks after consent, and once within 9-24 weeks after consent
Awards & highlights
RISES-T2 Trial Summary
This trial aims to find how electrical and magnetic stimulation can improve mobility in people with chronic spinal cord injuries.
Who is the study for?
This trial is for individuals with chronic spinal cord injury or disease, at least a year post-injury, who can engage in therapy and have caregiver support. They must be able to consent and participate in recorded sessions. Those with severe medical conditions, uncontrolled symptoms, skin issues where electrodes attach, active implants like pacemakers, or are pregnant/breastfeeding cannot join.Check my eligibility
What is being tested?
The RISES-T System is being tested to see how non-invasive electrical and magnetic neuromodulation techniques affect mobility in people with chronic spinal injuries. The study aims to find the best combination of these techniques to improve movement.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, temporary muscle twitching during treatment sessions, mild headaches or dizziness post-treatment. However, since it's non-invasive and doesn't involve drugs or surgery, serious side effects are less likely.
RISES-T2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ once at 2 weeks after consent, and once within 9-24 weeks after consent
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once at 2 weeks after consent, and once within 9-24 weeks after consent
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Manual Muscle Testing (MMT)
Modified Ashworth Scale (MAS)
Spinal Cord Injury-Motor Index (SCI MovIN)
Secondary outcome measures
Capabilities of Upper Extremity Test (CUE-T)
Numeric Pain Rating Scale (NPRS)
PROMIS Pain Interference- Adult Short Form 8a (PROMIS-PI)
+2 moreRISES-T2 Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental Treatment ArmExperimental Treatment1 Intervention
Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing repetitive task practice
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Who is running the clinical trial?
Tim ReynoldsUNKNOWN
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,704 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe health issues that could affect the study.My spinal injury is classified between A and D on the ASIA scale.I have skin damage where electrodes would be placed.I have severe, unstable autonomic dysreflexia or uncontrolled low blood pressure when standing.I can take part in physical and occupational therapy programs.I have heart or lung conditions that are not well-managed.My spinal cord injury is stable and not getting worse.My spasms prevent me from joining in study activities.My spinal cord injury is due to an autoimmune disease.I have injuries that could interfere with rehab or assessing its effects.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots available to join this research endeavor?
"Evidently, this clinical trial is not presently accepting candidates; the initial post was published on June 23rd 2023 and it has since been updated as recently as August 9th. Fortunately, 393 other medical trials are actively recruiting right now."
Answered by AI
What outcomes does this research hope to realize?
"The primary measure of progress in this clinical trial is Modified Ashworth Scale (MAS). Secondary objectives include PROMIS Pain Interference-Adult Short Form 8a (PROMIS-PI) which assesses the impact of pain on a patient's life, Walking Index for SCI (WISCI-II), to examine physical assistance and devices needed for walking following paralysis from spinal cord injury, as well as Numeric Pain Rating Scale(NPRS) which evaluates the intensity of subjective pain. Observations will be taken beginning 4 weeks after consent and reassessed every 2 weeks up to 22 weeks."
Answered by AI
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