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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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once at 2 weeks after consent, and once within 9-24 weeks after consent
This trial's timeline: 3 weeks for screening, Varies for treatment, and once at 2 weeks after consent, and once within 9-24 weeks after consent for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Manual Muscle Testing (MMT)
Modified Ashworth Scale (MAS)
Spinal Cord Injury-Motor Index (SCI MovIN)
Secondary study objectives
Capabilities of Upper Extremity Test (CUE-T)
Numeric Pain Rating Scale (NPRS)
PROMIS Pain Interference- Adult Short Form 8a (PROMIS-PI)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Tim ReynoldsUNKNOWN
Thomas Jefferson UniversityLead Sponsor
462 Previous Clinical Trials
175,528 Total Patients Enrolled

Media Library

Experimental Treatment Arm Clinical Trial Eligibility Overview. Trial Name: NCT05994846 — N/A
Spinal Cord Injury Research Study Groups: Experimental Treatment Arm
Spinal Cord Injury Clinical Trial 2023: Experimental Treatment Arm Highlights & Side Effects. Trial Name: NCT05994846 — N/A
Experimental Treatment Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05994846 — N/A
~3 spots leftby Jun 2025
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