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Device

Exoskeleton+Transcutaneous Spinal Cord Stimulation for Spinal Cord Injury

N/A

Recruiting

Research Sponsored by Craig Hospital

Eligibility Criteria Checklist

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

Must have

Medical clearance for high intensity gait training

Weight 220lbs or less

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to immediately after intervention

Awards & highlights

Study Summary

This trial aims to study the effects of combining transcutaneous spinal cord stimulation (TSCS) with exoskeleton training in individuals with incomplete spinal cord injury within 12 months of the injury.

Who is the study for?

This trial is for individuals under 12 months post-traumatic incomplete spinal cord injury (iSCI) between C4-T10, who can walk but slower than 1.46 m/s. They must be adults weighing no more than 220lbs with intact skin where the device will sit and have enough upper body strength to use a stability aid.Check my eligibility

What is being tested?

Researchers are testing if adding transcutaneous spinal cord stimulation (TSCS) to exoskeleton training helps improve walking, strength, muscle control, trunk balance, and bladder function better than exoskeleton training alone in those with iSCI.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, muscle fatigue from training sessions, and possible skin irritation from the exoskeleton device.

Eligibility Criteria

Inclusion Criteria

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

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I am medically cleared for intense walking exercises.

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I weigh 220lbs or less.

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I had a spinal cord injury between C4-T10 less than 12 months ago with upper motor neuron signs.

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My skin is healthy on my pelvis, legs, and back.

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I can use a tool like a cane or walker to help me stay balanced.

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My spinal injury is classified as AIS C or D.

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I am 18 years old or older.

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I walk slower than 1.46 meters per second.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to immediately after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to immediately after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to immediately after intervention 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 score on Walking Index for SCI (WISCI) II

Secondary outcome measures

Change in balance/trunk control as measure by the Function in Sitting Test Spinal Cord Injury

Change in bladder function as measured by Neurogenic Bladder Symptom Scale

Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Exoskeleton+Transcutaneous Spinal Cord StimulationExperimental Treatment1 Intervention

Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a therapeutic level of transcutaneous spinal cord stimulation (TSCS) thoracolumbar spinal cord areas. Focus will be on stepping at a high intensity throughout the session as measured by heart rate.

Group II: Exoskeleton+Sham StimluationPlacebo Group1 Intervention

Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a non-therapeutic level of stimulation (considered to be a sham). Focus will be on stepping at a high intensity throughout the session as measured by heart rate.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Craig HospitalLead Sponsor

40 Previous Clinical Trials

8,329 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available vacancies for patient participation in this clinical trial?

"Affirmative. Information from clinicaltrials.gov confirms the ongoing participant recruitment for this investigation. The trial was originally posted on November 15, 2023, and last modified on February 5, 2024. A total of 30 participants are sought at a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury

2023. "Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05982171.