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Procedure

Epidural Spinal Stimulation (ESS) for Spinal Cord Injury

N/A

Recruiting

Led By Dimitry Sayenko, MD, PhD

Research Sponsored by The Methodist Hospital Research Institute

Eligibility Criteria Checklist

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

Must have

Male or female, aged 22-60 years old

Able to self-transfer from the wheelchair and demonstrate active range of motion of bilateral upper extremities in gravity dependent plane

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline 1(week 1), baseline 2(week 6), post interventions (week 11), and follow up (week 16)

Awards & highlights

Study Summary

This trial aims to study how spinal cord stimulation can help people with spinal cord injuries regain the ability to stand and control their lower limbs. The researchers will focus on two types of stimulation, called epidural

Who is the study for?

This trial is for adults aged 22-60 with stable spinal cord injuries (1-6 years post-injury) below the neck and above the waist. They must be able to move their arms, sit upright for at least 15 minutes, and commit to the full study duration. Excluded are those with other ongoing conditions that limit physical activity, recent Botox injections in lower body muscles, or a BMI over 30.Check my eligibility

What is being tested?

The trial tests how non-invasive spinal stimulation techniques—Epidural Spinal Stimulation (ESS) and Transcutaneous Spinal cord Stimulation (TSS)—can help people regain standing ability after complete motor paralysis from spinal cord injury. It explores the electrical mechanisms of these treatments.See study design

What are the potential side effects?

Potential side effects may include discomfort at stimulation sites, muscle spasms, skin irritation from electrodes or adhesives used during TSS sessions, and possible fatigue due to exercise involved in therapy.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 60 years old.

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I can move from my wheelchair on my own and can move both arms freely.

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My spinal cord injury is not getting worse.

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I have a complete spinal cord injury classified as AIS A or B.

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My spinal cord injury is between my upper back and mid-back.

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I can move both of my legs normally without help.

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My spinal cord injury occurred between 1 and 6 years ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline 1(week 1), baseline 2(week 6), post interventions (week 11), and follow up (week 16)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline 1(week 1), baseline 2(week 6), post interventions (week 11), and follow up (week 16)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline 1(week 1), baseline 2(week 6), post interventions (week 11), and follow up (week 16) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Assessment of force generation by lower limbs

Secondary outcome measures

Assessment of Independence

Assessment of neurological status

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Epidural Spinal Stimulation (ESS)Experimental Treatment1 Intervention

Stimulation delivered internally using an implanted device operated by an external control (only used during research visits).

Group II: Transcutaneous Spinal Stimulation (TSS)Active Control1 Intervention

Spinal Stimulation delivered over the skin using a research stimulator with conventional surface electrodes during research visits.

Group III: ShamPlacebo Group1 Intervention

Sham Stimulation delivered over the skin using a research stimulator with conventional surface electrodes during research visits. Sham stimulation will be delivered using the intensity of stimulation set as during active sessions of ESS, but then gradually decreased down to zero in approximately 30 s. There will be 5-10 minute breaks interspersed between intervals of stimulation, and will vary according to the individual's tolerance and fatigue levels

0 / 7Eligibility criteria met

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Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH

1,341 Previous Clinical Trials

649,329 Total Patients Enrolled

The Methodist Hospital Research InstituteLead Sponsor

274 Previous Clinical Trials

80,475 Total Patients Enrolled

Dimitry Sayenko, MD, PhDPrincipal InvestigatorThe Methodist Hospital Research Institute

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

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

Do I meet the necessary criteria to be considered for enrollment in this clinical trial?

"To be considered eligible for participation in this clinical study, patients should possess a spinal cord injury and fall within the age range of 22 to 60. The trial is currently accepting a total of 60 participants."

Answered by AI

Is the recruitment phase of this clinical trial still ongoing?

"According to the information provided on clinicaltrials.gov, this trial is currently in the active recruitment phase. The initial posting date was December 6th, 2023 and it underwent its most recent update on January 8th, 2024."

Answered by AI

What is the current number of individuals who have been granted admission to participate in this clinical study?

"Indeed, the information on clinicaltrials.gov confirms that this trial is presently seeking participants. The initial posting of the clinical trial was made on December 6th, 2023 and it was last updated on January 8th, 2024. The study aims to enroll a total of 60 patients from one designated site."

Answered by AI