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Electrical Stimulation

Wearable Electrical Stimulation for Spinal Cord Injury (RISES-T Trial)

N/A

Waitlist Available

Led By Mijail D Serruya, MD, PhD

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 between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up repeated measurements once every 6 weeks throughout the study, an average of 3 months

Awards & highlights

RISES-T Trial Summary

This trial will look at how electrical stimulation of the spinal cord can help people with paralysis due to SCI improve their strength and function in their arms, legs, hands, and feet.

Who is the study for?

This trial is for individuals with non-progressive spinal cord injuries from C2-T10, at least one year post-injury, and classified as B, C, or D on the ASIA scale. Participants must be able to consent and engage in physical therapy with caregiver support. It's not suitable for those with severe cardiopulmonary disease, unexcitable muscles due to lower motor neuron injury, severe neuropathic pain or cognitive disorders, skin breakdown where electrodes are placed, active implanted devices or pregnancy.Check my eligibility

What is being tested?

The RISES-T System is being tested alongside occupational/physical therapy to see if 'smart' electrical stimulation can improve movement in people paralyzed by spinal cord injuries. The study involves exercises paired with targeted spinal stimulation to potentially enhance arm and leg function.See study design

What are the potential side effects?

Potential side effects may include discomfort at the electrode sites on the back during electrical stimulation sessions. There might also be a risk of muscle fatigue from increased activity during therapy sessions.

RISES-T Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ repeated measurements once every 6 weeks throughout the study, an average of 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~repeated measurements once every 6 weeks throughout the study, an average of 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and repeated measurements once every 6 weeks throughout the study, an average of 3 months 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 from Baseline- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)

Secondary outcome measures

Change from 10 Meter Walk Test (10MWT) and Walking Index for Spinal Cord Injury (WISCI II)

Change from Baseline - Canadian Occupational Performance Measure (COPM)

Change from Baseline - Capabilities of Upper Extremity (CUE-T)

+1 more

RISES-T Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment2 Interventions

Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing functional task practice in occupational therapy sessions.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

444 Previous Clinical Trials

145,620 Total Patients Enrolled

Kessler FoundationOTHER

173 Previous Clinical Trials

10,704 Total Patients Enrolled

Mijail D Serruya, MD, PhDPrincipal InvestigatorThomas Jefferson University

Media Library

RISES-T System (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05669508 — N/A

Spinal Cord Injury Research Study Groups: Treatment Arm

Spinal Cord Injury Clinical Trial 2023: RISES-T System Highlights & Side Effects. Trial Name: NCT05669508 — N/A

RISES-T System (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05669508 — N/A

Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT05669508 — N/A

Frequently Asked Questions

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

Does this research endeavor accommodate individuals aged 70 and beyond?

"Those wishing to join this trial must be between the ages of 18 and 55. Meanwhile, 36 studies are available for minors while 327 exist that cater to those over 65."

Answered by AI

Does this medical trial currently accept participants?

"Affirmative. According to clinicaltrials.gov, this investigation is currently accepting enrolment applications; the trial was originally posted on February 10th 2022 and has been updated as of December 19th 2022. There is a requirement for 10 participants at 1 site."

Answered by AI

How many participants are being enrolled in this clinical research?

"Affirmative. According to what is currently accessible on clinicaltrials.gov, this study is actively recruiting participants and was first posted in February 10th 2022 with the last update made December 19th 2022. The recruitment process requires enlisting 10 qualified individuals from a single medical centre."

Answered by AI

To which demographic does the recruitment for this experiment apply?

"This study is attempting to enrol 10 individuals with spinal cord injuries between 18 and 55 years of age. To be eligible, participants must meet the following criteria: Non-progressive or central cord injury from C2-T10 inclusive; ASIA Impairment Scale (AIS) classification B,C,or D; able to participate in physical/occupational therapy programs for at least 12 months post SCI; can provide informed consent; has adequate caregiver support."

Answered by AI