Epidural Stimulation After Spinal Cord Injury

NCT04105296 | Unknown Phase 1 DMC FDA Device

• 1 other identifier: 2501
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

• Six minute-walk and 10-meter walk distance Tests

  Walking distance and speed will also be determined

  6 months

• Surface electromyography of 6 different muscle groups

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

  6 months

Secondary Outcomes (3)

• Systolic and Diastolic Blood Pressure

  6 months

• Oxygen uptake using Portable Indirect Calorimetry

  6 months

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

  6 months

Study Arms (1)

EKSO+ES

EXPERIMENTAL

6 months of exoskeleton training with spinal cord epidural stimulation.

Device: EKSO+ES

Interventions

EKSO+ES DEVICE

6 months of exoskeleton training with epidural stimulation.

EKSO+ES

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• McGuire Research Institute: lead

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ashraf S Gorgey, PhD

  Hunter Holmes McGuire VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashraf S Gorgey, PhD

CONTACT

8046755000; ashraf.gorgey@va.gov

Robert Trainer, MD

CONTACT

Robert.Trainer@va.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 26, 2019
• Study Start: January 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 3, 2019

Record last verified: 2019-10

Locations

US (1)