Neuromodulation Techniques After SCI

NCT04241250 | Completed Phase 2 Results DMC FDA Device

• 1 other identifier: B3456-P
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injury (SCI) leads to several health-related consequences often linked to reduced levels of physical activity. Direct stimulation of the spinal cord, either through implanted devices or surface stimulation, has been combined with intense physical therapy assisted treadmill walking to facilitate independent standing and stepping. These current methods require 3-4 highly skilled therapists and may not be feasible in all rehabilitation settings, especially when considering the growing number of SCI patients each year. Therefore, the use of robotic exoskeleton suits combined with direct stimulation of the spinal cord (requiring 1-2 therapists) may offer an alternative rehabilitation approach to overcome their limited abilities to stand and walk. Such improvements may also help to reverse or eliminate other health-related consequences associated with SCI. The pilot work will provide the preliminary evidence required to design future clinical trials for Veterans and civilians with SCI to restore overground mobility.

Conditions

Spinal Cord Injury

Keywords

Robotic Exoskeleton; Epidural Stimulation; Transspinal stimulation; Spinal cord injury; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 10-meter Walking Speed (m/Sec)

  After fitted in the robotic exoskeleton, the participant will be asked to walk for 10-meter distance and the time and speed will be determined. Measurements were conducted over the course of 9 months.

  Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)

• Muscles Electromyography (EMG) Activity (Micro-volts)

  Representative EMG activities of the right VL muscle during the entire gait cycle of the 10 meter walking test at baseline (BL) and post-intervention (PI) measurements over the course of 9 months. In the EAW+SECES, participants had undergone EMG measurements during exoskeletal-10-meter walking test at baseline (BL) and after 6 months (P3) following implantation of spinal cord epidural stimulation (SCES). The EMG tests were performed at 100% exoskeletal assisted walking (EAW) or reduced EAW (RED-EAW) at Baseline and P3. At P3, the EMG tests were performed three times; one at 100%-EAW, RED-EAW without SCES and RED-EAW with SCES.

  Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)

Secondary Outcomes (4)

• Percentage Fat Mass

  Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)

• Oxygen Uptake (L/Min)

  [Time Frame: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)]

• Fasting Lipid Profile (mg/dl)

  [Time Frame: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)]

• Fat-Free Mass

  Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)

Other Outcomes (1)

• Volume of Bladder Capacity During Filling and Voiding (ml)

  [Time Frame: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)]

Study Arms (2)

EAW+SCES

EXPERIMENTAL

Three months of exoskeleton training followed by 6 months of epidural stimulation.

Device: EAW+SCES (exoskelton and spinal cord epidural stimulation)

EAW+TS

EXPERIMENTAL

Three months of exoskeleton training followed by 6 months of transspinal stimulation.

Device: EAW+TS (exoskelton and transspinal stimulation)

Interventions

EAW+TS (exoskelton and transspinal stimulation) DEVICE

Three months of exoskeleton training followed by 6 months of transspinal stimulation.

EAW+TS

EAW+SCES (exoskelton and spinal cord epidural stimulation) DEVICE

Three months of exoskeleton training followed by 6 months of epidural stimulation.

EAW+SCES

Eligibility Criteria

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

You may qualify if:

• All participants will be between 18-70 years old, male, with traumatic motor complete SCI and level of injury of T10 and above, as determined by EMG testing and International Standards for Neurological Classification of SCI (ISNCSCI) exam
• All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included

You may not qualify if:

• Participants with any of the following pre-existing medical conditions will be excluded from the current trial:
• Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia
• Unhealed fracture in either lower or upper extremities
• Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture greater than 20 degrees
• Untreated or uncontrolled hypertension defined as high resting blood pressure greater than 140/90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHg compared to resting supine blood pressure) or incapable to maintain a sitting or EAW standing posture
• 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
• DXA T-Score less than -2.5. Scans done will include total body, dual hips and knees. Total hip BMD T-scores \< -3.5 and knee BMD scores of less than 0.6 g/cm2
• Functional upper and lower extremity 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 from the trial
• This is based on the Ekso manufacturer's recommendations
• Untreatable severe spasticity judged to be contraindicated by the site Physician

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Virginia Commonwealth University: collaborator

Study Sites (1)

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249-0001, United States

Location

Related Publications (4)

• Hachmann JT, Yousak A, Wallner JJ, Gad PN, Edgerton VR, Gorgey AS. Epidural spinal cord stimulation as an intervention for motor recovery after motor complete spinal cord injury. J Neurophysiol. 2021 Dec 1;126(6):1843-1859. doi: 10.1152/jn.00020.2021. Epub 2021 Oct 20.

  PMID: 34669485 BACKGROUND

• Gorgey AS, Trainer R, Sutor TW, Goldsmith JA, Alazzam A, Goetz LL, Lester D, Lavis TD. A case study of percutaneous epidural stimulation to enable motor control in two men after spinal cord injury. Nat Commun. 2023 Apr 12;14(1):2064. doi: 10.1038/s41467-023-37845-7.

  PMID: 37045845 RESULT

• Alazzam AM, Ballance WB, Smith AC, Rejc E, Weber KA 2nd, Trainer R, Gorgey AS. Peak Slope Ratio of the Recruitment Curves Compared to Muscle Evoked Potentials to Optimize Standing Configurations with Percutaneous Epidural Stimulation after Spinal Cord Injury. J Clin Med. 2024 Feb 27;13(5):1344. doi: 10.3390/jcm13051344.

  PMID: 38592158 RESULT

• Gorgey AS, Goldsmith J, Alazzam A, Trainer R. Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. Front Neurosci. 2023 Feb 16;17:1112853. doi: 10.3389/fnins.2023.1112853. eCollection 2023.

  PMID: 36875669 RESULT

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

Results Point of Contact

• Title: Ashraf S. Gorgey
• Organization: Central Virginia VA Hospital

ashraf.gorgey@va.gov

8046755000

Study Officials

• Ashraf Gorgey, PhD PT

  Hunter Holmes McGuire VA Medical Center, Richmond, VA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Exoskeletal assisted walking and spinal cord epidural stimulation (EAW+SCES) Exoskeletal assisted walking and Transspinal stimulation (EAW+TS)

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 27, 2020
• Study Start: June 1, 2020
• Primary Completion: July 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)