AzTrials
AzTrials

Spinal Cord InjuriesPhase 1/2ESL-SCINCT04105296

Epidural Stimulation After Spinal Cord Injury

A Phase 1/2 study testing EKSO+ES in people with Spinal Cord Injuries, run by McGuire Research Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The purpose of the current study is to determine the effects of applying epidural stimulation (ES) on motor control recovery in Veterans with SCI. The intervention will be accompanied with the use of a powered exoskeleton (EKSO®) for 6 months to facilitate standing and to produce step-like movement in persons with… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
EKSO+ES
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
Jan 2020to 30 Dec 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A written clearance by the medical doctor to ensure that the participant is safely able to engage in the program.
  • Participants who require assistance with activities of daily living, must have a caregiver or companion with them throughout their participation in the study.
  • Participants will have to be 2 years post-injury with any level of injury below C5 and using wheelchair as the primary mode of mobility. The study is primarily exploratory, and all participants will be between 18-70 years old with SCI.
  • Hip width (distance between two greater trochanters), upper leg length (greater trochanter to the lateral aspect of joint line of the knee joint) and lower leg length (lateral aspect of joint line of the knee joint to the bottom of the foot) that can fit the robotic suit.

Who cannot join

  • Unhealed fracture in either lower or upper extremities
  • Severe scoliosis, hip knee ROM or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion deformity greater than 20 degrees.
  • High resting blood pressure greater than 140/80 mmHg and or sudden hypotension upon standing as characterized by drop in blood pressure by 20 mmHg especially in persons with tetraplegia.
  • Other medical conditions including cardiovascular disease, uncontrolled type II DM, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater, or symptomatic urinary tract infection.
  • Unable to fit in the device for any reason.
  • Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons.
Show all 18Show fewer
  • Implanted pacemakers and/or implanted defibrillator devices.
  • Any condition that, in the judgment of the principal investigator or medical provider, precludes safe participation in the study and/or increases the risk of infection.
  • Dual Energy X-ray Absorptiometry (DXA) T-Score less than -2.5. Scans done will include total body, dual hips and knees.
  • Functional upper and lower extremity range of motion (ROM), strength, spasticity and skin integrity will also have assessed prior to enrollment in the program. The Modified Ashworth Scale will be used to ensure safety of the participants prior to engagement in the rehabilitation program. Participants with severe spasticity or limited ROM will be excluded in the trial. This will be done based on the manufacture's recommendation.
  • Other exclusion criteria may include the followings
  • subjects with uncontrolled autonomic dysreflexia
  • subjects with concurrent severe neurological injuries other than SCI: MS, CP, TBI, stroke;
  • subjects with unresolved deep vein thrombosis (DVT);
  • subjects with prosthetic lower limbs;
  • subjects with psychiatric or cognitive impairments which will interfere with proper operation of both the spinal cord stimulator as well as the exoskeleton;
  • subjects with an unhealed spinal fracture or unstable spine; and
  • subjects with known cardiac pathology which precludes safe participation

Trial locations and contacts

1 site in 1 country.

Ashraf S Gorgey, PhD contact

8046755000 ext. 3386

ashraf.gorgey@va.gov

Robert Trainer, MD contact

Robert.Trainer@va.gov

United States1 site

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249

Other trials in United States

About this study

Official title: Epidural Stimulation for Locomotion After Spinal Cord Injury

The purpose of the current study is to determine the effects of applying epidural stimulation (ES) on motor control recovery in Veterans with SCI. The intervention will be accompanied with the use of a powered exoskeleton (EKSO®) for 6 months to facilitate standing and to produce step-like movement in persons with chronic motor complete (AIS A or B) SCI and level of injury below C5 . Walking speed, distance, muscle activation pattern as measured by surface EMG and walking parameters including stand-up time, walking time, distance will be considered primary outcome variables. Cardiovascular performance, as measured by resting blood pressure and heart rate, peak oxygen consumption during walking, energy expenditure, whole and regional body composition assessments will also be measured. The effects of training (ES+EKSO) on , and speed of walking will also be evaluated.

Read the detailed description

Five veterans with chronic motor complete SCI (AIS A or B) will be recruited to participate in the current trial. The primary objective is to determine how implantation of an epidural stimulator can help to control movement in the leg muscles to stand and perform stepping. Participants will be trained using a robotic suit and parallel bars. The procedure of using epidural stimulation with the robotic suit is experimental. The participant will be scheduled to perform temporary implantation followed by permanent implantation. Seven days later, two 8-electrode arrays of Vectris lead will be implanted in an operating room. The research team will be responsible for helping the participants to trigger the paralyzed muscles from supine and sitting using for 5 days per week. Participants would be required to come for study visits twice daily for 2 hours per day. Each visit will last approximately 1 hour in the morning and 1 hour in the evening. During these visits, participants will practice walking with a robotic suit for 30-60 minutes followed by overground walking between parallel bars, or with a walker or crutches.

Being tested
EKSO+ES
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EKSO+ESDevice

    6 months of exoskeleton training with epidural stimulation.

Study groups in NCT04105296
Study groupRoleWhat they receive
EKSO+ESExperimental6 months of exoskeleton training with spinal cord epidural stimulation.
Receives: Device: EKSO+ES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six minute-walk and 10-meter walk distance Tests

    Walking distance and speed will also be determined

    Measured: 6 months

  2. Surface electromyography of 6 different muscle groups

    The EMG activity from 6 major leg muscles will be measured during locomotion

    Measured: 6 months

Secondary outcomes (3)

  1. Systolic and Diastolic Blood Pressure

    During sitting, standing and walking

    Measured: 6 months

  2. Oxygen uptake using Portable Indirect Calorimetry

    During sitting, standing and walking

    Measured: 6 months

  3. Body composition assessment of fat mass and fat-free mass using dual energy x-ray absorptiometry (DXA)

    Before and after training

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2019
  2. Study startJan 2020 (estimated)
  3. Primary completion30 Dec 2021 (estimated)
  4. Study completion30 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04105296
Sponsor's protocol ID
2501
Acronym
ESL-SCI
Status last verified
Oct 2019
First submitted
23 Sep 2019
Last updated
3 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: IPD will be available in the form of published case reports as well as scientific presentations in national and international meetings.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EKSO+ES in people with Spinal Cord Injuries, run by McGuire Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ashraf S Gorgey, PhD (8046755000 ext. 3386, ashraf.gorgey@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six minute-walk and 10-meter walk distance Tests (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04105296.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in