Epidural Stimulation After Spinal Cord Injury (ESL-SCI)
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ClinicalTrials.gov Identifier: NCT04105296 |
Recruitment Status : Unknown
Verified October 2019 by McGuire Research Institute.
Recruitment status was: Not yet recruiting
First Posted : September 26, 2019
Last Update Posted : October 3, 2019
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Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injuries | Device: EKSO+ES | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Device Feasibility |
Official Title: | Epidural Stimulation for Locomotion After Spinal Cord Injury |
Estimated Study Start Date : | January 2020 |
Estimated Primary Completion Date : | December 30, 2021 |
Estimated Study Completion Date : | December 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: EKSO+ES
6 months of exoskeleton training with spinal cord epidural stimulation.
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Device: EKSO+ES
6 months of exoskeleton training with epidural stimulation. |
- Six minute-walk and 10-meter walk distance Tests [ Time Frame: 6 months ]Walking distance and speed will also be determined
- Surface electromyography of 6 different muscle groups [ Time Frame: 6 months ]The EMG activity from 6 major leg muscles will be measured during locomotion
- Systolic and Diastolic Blood Pressure [ Time Frame: 6 months ]During sitting, standing and walking
- Oxygen uptake using Portable Indirect Calorimetry [ Time Frame: 6 months ]During sitting, standing and walking
- Body composition assessment of fat mass and fat-free mass using dual energy x-ray absorptiometry (DXA) [ Time Frame: 6 months ]Before and after training

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105296
Contact: Ashraf S Gorgey, PhD | 8046755000 ext 3386 | ashraf.gorgey@va.gov | |
Contact: Robert Trainer, MD | Robert.Trainer@va.gov |
United States, Virginia | |
Hunter Holmes McGuire VA Medical Center | |
Richmond, Virginia, United States, 23249 |
Principal Investigator: | Ashraf S Gorgey, PhD | Hunter Holmes McGuire VA Medical Center |
Responsible Party: | McGuire Research Institute |
ClinicalTrials.gov Identifier: | NCT04105296 |
Other Study ID Numbers: |
2501 |
First Posted: | September 26, 2019 Key Record Dates |
Last Update Posted: | October 3, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | IPD will be available in the form of published case reports as well as scientific presentations in national and international meetings. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Spinal Cord Injuries Wounds and Injuries Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |