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TSS + MST for Spinal Cord Injury

N/A

Recruiting

Led By Edelle C Field-Fote, PT, PhD

Research Sponsored by Shepherd Center, Atlanta GA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be 18-70 years of age

Able to move each leg independently for at least 3 steps (with or without the aid of an assistive device)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up testing 1(day 1), testing 2 (day 12), training 1-6 (days 15, 17, 19, 22, 24, 26), testing 3 (day 27)

Awards & highlights

Study Summary

This trial is testing whether a combination of spinal stimulation and motor skill training can help improve walking function in people with spinal cord injuries, compared to motor skill training alone.

Who is the study for?

This trial is for adults aged 18-70 with spinal cord injuries at levels C3-T12, who can independently move each leg and stand with assistance. They must be stable on spasticity medications for at least two weeks and not have progressive spine disorders, implanted stimulators, skin issues near the stimulation site, cardiovascular irregularities, or cancer.Check my eligibility

What is being tested?

The study tests if motor skill training (MST) improves walking in people with spinal cord injury and whether adding transcutaneous spinal stimulation (TSS) leads to greater improvements. Participants will receive MST alone or combined with TSS to see which method better enhances walking ability.See study design

What are the potential side effects?

Potential side effects of TSS may include discomfort or skin irritation where the device attaches. MST could lead to muscle soreness or fatigue due to physical activity involved in the training.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I can walk at least 3 steps on my own, with or without help from a device.

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I can stand up with some help from one person.

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My spinal cord injury is classified as moderate to severe.

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I can stand for at least 5 minutes, with or without help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ testing 1(day 1), testing 2 (day 12), training 1-6 (days 15, 17, 19, 22, 24, 26), testing 3 (day 27)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~testing 1(day 1), testing 2 (day 12), training 1-6 (days 15, 17, 19, 22, 24, 26), testing 3 (day 27)

This trial's timeline: 3 weeks for screening, Varies for treatment, and testing 1(day 1), testing 2 (day 12), training 1-6 (days 15, 17, 19, 22, 24, 26), testing 3 (day 27) 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 10 Meter Walk Test

Secondary outcome measures

Change of 2 Minute Walk Test

Change of Berg Balance Scale

Change of Falls Efficacy Scale-International Version (FES-I)

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MST + TSSExperimental Treatment2 Interventions

Individuals will participate in 6 training sessions of MST combined with TSS.

Group II: MST + ShamTSSPlacebo Group1 Intervention

Individuals will participate in 6 training sessions of MST while receiving shamTSS.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Shepherd Center, Atlanta GALead Sponsor

28 Previous Clinical Trials

3,623 Total Patients Enrolled

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED

71 Previous Clinical Trials

9,101 Total Patients Enrolled

Edelle C Field-Fote, PT, PhDPrincipal InvestigatorShepherd Center, Atlanta GA

6 Previous Clinical Trials

287 Total Patients Enrolled

Media Library

Motor Skill Training Clinical Trial Eligibility Overview. Trial Name: NCT05429736 — N/A

Spinal Cord Injury Research Study Groups: MST + TSS, MST + ShamTSS

Spinal Cord Injury Clinical Trial 2023: Motor Skill Training Highlights & Side Effects. Trial Name: NCT05429736 — N/A

Motor Skill Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05429736 — N/A

Frequently Asked Questions

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

Are senior citizens within the age bracket of 70 or below eligible for this clinical trial?

"As stated in the requirements for entry, potential participants need to be 18 years old or above and 70 or below."

Answered by AI

Are patients currently being welcomed to participate in this investigation?

"Affirmative. The information available on clinicaltrials.gov indicates that this medical research is actively recruiting participants, with 40 patients needed from a single site since the study's inception in March 2022 and latest update November 18th of the same year."

Answered by AI

Is participation in this experiment open to me?

"This medical trial is recruiting 40 individuals between 18 and 70 years old with spasticity due to spinal cord injury. The enrolment criteria includes: being within the specified age range, having a SCI of C3-T12 for at least 3 months (subacute/chronic), ISNCSCI severity classification of either C or D, authorization to share personal health information, capability to comprehend multiple instructions and communicate pain or discomfort, capacity to remain standing for 5 minutes with/without assistive device(s), leg movement control enabling one person assisted stand from sitting position as well as walk three steps independently utilising aid if necessary"

Answered by AI

How many participants are eligible for inclusion in this clinical trial?

"Affirmative. The clinical trial is actively searching for eligible candidates, with the initial post made on March 1st 2022 and last updated November 18th 2022. 40 individuals are expected to join this study at one specified medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity

Edelle Field-Fote, PT, PhD 2022. "Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429736.