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Epidural Stimulation for Multiple Sclerosis

N/A

Recruiting

Research Sponsored by Kristin Zhao, PhD

Eligibility Criteria Checklist

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

Must have

No clinical or radiologic MS relapses for > 5 years

Able to ambulate 10 feet independently with or without gait aid use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; approximately 4 weeks.

Awards & highlights

Study Summary

This trial studied how MS patients' physical abilities changed with 12 physical therapy sessions involving electrical stimulation.

Who is the study for?

This trial is for adults over 22 with progressive MS who can walk 10 feet independently and have had stable symptoms for over 5 years. They must not be pregnant, in prison, or have a history of severe infections or blood disorders. Participants should not be on certain medications or involved in other clinical trials.Check my eligibility

What is being tested?

The study tests the effects of percutaneous epidural stimulation on motor performance in progressive MS patients across 12 rehab sessions. It aims to understand how this treatment might help improve movement abilities.See study design

What are the potential side effects?

While specific side effects are not listed, epidural stimulation may include risks such as infection at the electrode site, bleeding, nerve damage, headache, and discomfort where the device is implanted.

Eligibility Criteria

Inclusion Criteria

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

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I haven't had MS symptoms or relapses in over 5 years.

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I can walk 10 feet on my own, with or without help from a device.

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I am 22 years old or older.

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I haven't changed my spasticity or dalfampridine medication in the last 3 months.

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I have spinal cord damage due to progressive MS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; approximately 4 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; approximately 4 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; approximately 4 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Electromyography (EMG)

Kinematics

Kinetics

+2 more

Secondary outcome measures

Bladder Control

Bowel Control

Cognitive Dysfunction

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Percutaneous Epidural StimulationExperimental Treatment1 Intervention

Epidural spinal stimulation will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of epidural stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kristin Zhao, PhDLead Sponsor

6 Previous Clinical Trials

95 Total Patients Enrolled

Mayo ClinicOTHER

3,216 Previous Clinical Trials

3,767,478 Total Patients Enrolled

1 Trials studying Autoimmune Diseases

4,618 Patients Enrolled for Autoimmune Diseases

Frequently Asked Questions

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

Is the enrollment process for this research project open at present?

"According to clinicaltrials.gov, this medical trial is not currently enrolling participants. It was posted for the first time on September 1st 2023 and had its last update on August 25th 2023. Despite that fact, there are still 598 other active studies recruiting patients right now."

Answered by AI

What objectives does this clinical experiment hope to accomplish?

"This medical experiment aims to evaluate the kinetics of its primary outcome, assessed over a four week period. Secondary objectives include assessing changes in mobility with The Timed Up and Go Test; gauging balance capabilities using the Berg Balance Scale; and rating disability levels through questions on the Short Form (36) Health Survey."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Epidural Stimulation in Multiple Sclerosis

Kristin Zhao, PhD 2023. "Epidural Stimulation in Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06019611.

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