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Non-invasive Spinal Stimulation for Spinal Cord Injury

N/A
Waitlist Available
Led By Andrea L Behrman, PT, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic (> 1 year since injury), Acquired Upper motor Neuron injury (T10 and above)
Discharged from in-patient rehabilitation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (pre-intervention), after 60 intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test the efficacy of multi-modal training combining activity-based locomotor training and transcutaneous spinal stimulation (ABLT+scTS) to improve sitting posture and trunk control in children with a chronic spinal cord injury.

Who is the study for?
This trial is for children aged 3-12 with chronic spinal cord injuries at T10 or above, who are not able to walk and have moderate to severe trunk control issues. They should be new to both activity-based locomotor training and transcutaneous spinal stimulation, and must have been out of in-patient rehab for over a year.Check my eligibility
What is being tested?
The study tests if combining locomotor training with non-invasive spinal stimulation can help improve sitting posture and trunk control in kids with long-term spinal cord injuries. It will involve 12 participants who haven't tried this method before.See study design
What are the potential side effects?
Potential side effects aren't specified here, but similar treatments may cause discomfort at the stimulation site, skin irritation, or muscle fatigue during or after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had an upper body nerve injury for over a year.
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I have been discharged from in-patient rehab.
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I struggle with sitting up straight or reaching without losing my balance.
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I have never had locomotor training or spinal stimulation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (pre-intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (pre-intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Modified Function Reach (MFR)
Segmental Assessment of Trunk Control
Secondary outcome measures
Angular Excursions of the Trunk
Center of Pressure (CoP) displacement

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: Transcutaneous spinal stimulationExperimental Treatment1 Intervention
Participants with chronic SCI will receive 60 sessions of activity based-locomotor training (AB-LT) combined with transcutaneous stimulation (scTS).

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
334 Previous Clinical Trials
76,007 Total Patients Enrolled
The Craig H. Neilsen FoundationOTHER
53 Previous Clinical Trials
2,867 Total Patients Enrolled
Andrea L Behrman, PT, PhDPrincipal InvestigatorUniversity of Louisville
2 Previous Clinical Trials
18 Total Patients Enrolled

Media Library

Biostim-5/Neostim transcutaneous spinal stimulator Clinical Trial Eligibility Overview. Trial Name: NCT05091463 — N/A
Spinal Cord Injury Research Study Groups: Transcutaneous spinal stimulation
Spinal Cord Injury Clinical Trial 2023: Biostim-5/Neostim transcutaneous spinal stimulator Highlights & Side Effects. Trial Name: NCT05091463 — N/A
Biostim-5/Neostim transcutaneous spinal stimulator 2023 Treatment Timeline for Medical Study. Trial Name: NCT05091463 — N/A

Frequently Asked Questions

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

Will individuals aged 65 and above be allowed to partake in this experiment?

"The age range for this research project is between 3 and 12 years old."

Answered by AI

Has recruitment for this experiment commenced?

"Contrary to expectations, clinicaltrials.gov reveals that this study is no longer in need of participants; the original posting was on August 31st 2021 and it had been updated lastly on October 22nd 2021. Nonetheless, there are currently 352 other trials which require patient enrollment."

Answered by AI

Is there an opportunity for me to partake in this medical experiment?

"The eligibility criteria for this trial stipulates that participants must have a spinal cord injury and be between the ages of 3 to 12. The research team is looking for a cohort size of 12 patients in total."

Answered by AI
~2 spots leftby Jul 2024