Spinal Cord Injury Epidural Stimulation

Spinal Cord Injury Clinical Trial

Official title:

A Feasibility Study: Epidural Stimulation to Enable Volitional Movement After Chronic Complete Paralysis in Humans.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592668
• Other study ID #: 15-000510
• Secondary ID: UL1TR000135
• Status: Completed
• Phase: N/A
• Start date: January 4, 2016
• Est. completion date: February 11, 2019

Study information

• Verified date: April 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a feasibility study to test the use of epidural stimulation to restore volitional function previously lost due to spinal cord injury.

Previous studies conducted in animal models, performed elsewhere and here at Mayo Clinic, have shown that direct electrical stimulation of the spinal cord increases the excitability of spared neuronal connections within the site of injury, thereby enhancing signal transmission and allowing recovery of previously lost volitional function. Recently, epidural electrical stimulation of the lumbosacral spinal cord in four individuals with spinal cord injury (SCI) has restored motor and autonomic function below the level of injury. Despite positive results, further translational research is needed to validate these findings. The goal of this proposal is to perform epidural stimulation to restore volitional function in patients with SCI. In two patients, we will implant an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: February 11, 2019
• Est. primary completion date: September 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Stable medical condition without *cardiopulmonary disease or *dysautonomia that would contraindicate standing or stepping with body weight support training

• No current anti-spasticity medication regimen

• Non-progressive spinal cord injury between the vertebral levels of C7 & T10

• American Spinal Injury Association grading scale of A or B

• Sensory evoked potentials are either not present or have a bilateral delay

• Segmental reflexes remain functional below the lesion

• At least 2-years post-injury.

Exclusion Criteria:

• Pregnancy at time of enrollment

• Failure to obtain consent

• Prisoners

• Children (age less than 21)

• Any patient identified as unsuitable for this protocol by the Mayo study team

• Skeletal fracture

• Osteoporosis with Dual-energy X-ray absorptiometry (DEXA) t score =-3.5

• Uncontrolled urinary tract infections

• Presence or history of frequent decubitus ulcers

• Clinical depression

• Drug abuse

• Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training

• Current anti-spasticity medication regimen

• Voluntary motor response present in leg muscles

• Volitional control during voluntary movement attempts in leg muscles as measured by electromyography (EMG) activity

• Brain influence on spinal reflexes as measured by EMG activity

• Recordable motor evoked potential in the lower limbs with transcranial magnetic stimulation

• Implanted cardiac pacemaker

• Implanted defibrillator

• Other implanted metallic or active body worn medical electronic device such as an insulin pump

• *Cardiopulmonary disease that would result in exclusion from the study will be defined as clinically diagnosed chronic obstructive pulmonary disease, cardiac failure, and heart arrhythmia that would contraindicate sudden changes in body position such as sit-to-stand and stepping

• *Excessive and uncontrolled autonomic dysreflexia characterized by symptomatic hypotension, light headedness and hypertension, flushing and bradycardia. Additionally blood pressure monitoring will be available at all times during rehabilitation and assessment times.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• Epidural Stimulator
Subjects will be implanted with an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (6)

Lead Sponsor	Collaborator
Mayo Clinic	Bel13ve in Miracles Foundation, National Center for Advancing Translational Science (NCATS), Reneu Health Inc., The Craig H. Neilsen Foundation, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (3)

Calvert JS, Grahn PJ, Strommen JA, Lavrov IA, Beck LA, Gill ML, Linde MB, Brown DA, Van Straaten MG, Veith DD, Lopez C, Sayenko DG, Gerasimenko YP, Edgerton VR, Zhao KD, Lee KH. Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis. J Neurotrauma. 2019 May 1;36(9):1451-1460. doi: 10.1089/neu.2018.5921. Epub 2018 Dec 15. — View Citation

Gill ML, Grahn PJ, Calvert JS, Linde MB, Lavrov IA, Strommen JA, Beck LA, Sayenko DG, Van Straaten MG, Drubach DI, Veith DD, Thoreson AR, Lopez C, Gerasimenko YP, Edgerton VR, Lee KH, Zhao KD. Neuromodulation of lumbosacral spinal networks enables independent stepping after complete paraplegia. Nat Med. 2018 Nov;24(11):1677-1682. doi: 10.1038/s41591-018-0175-7. Epub 2018 Sep 24. Erratum in: Nat Med. 2018 Oct 23;:. — View Citation

Grahn PJ, Lavrov IA, Sayenko DG, Van Straaten MG, Gill ML, Strommen JA, Calvert JS, Drubach DI, Beck LA, Linde MB, Thoreson AR, Lopez C, Mendez AA, Gad PN, Gerasimenko YP, Edgerton VR, Zhao KD, Lee KH. Enabling Task-Specific Volitional Motor Functions via Spinal Cord Neuromodulation in a Human With Paraplegia. Mayo Clin Proc. 2017 Apr;92(4):544-554. doi: 10.1016/j.mayocp.2017.02.014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of time for which subject can sit unassisted on the edge of a mat table		Approximately 50 weeks after implantation
Primary	Assessment of volitional movement of lower limbs		Approximately 50 weeks after implantation
Primary	Subject's ability to coordinate stepping on a treadmill will be measured using biomechanical and electrophysiological analyses		Approximately 50 weeks after implantation
Primary	Duration of time for which subject can stand weight bearing with minimal assistance provided as needed.		Approximately 50 weeks after implantation
Secondary	Change in volitional movement restoration via NeuroRecovery scale		baseline, approximately 50 weeks after implantation
Secondary	Change of bladder function, as measured by the Neurogenic Bladder Symptom Score questionnaire		baseline, approximately 50 weeks after implantation
Secondary	Change in sexual function as measured by the Sexual Function Questionnaire		baseline, approximately 50 weeks after implantation
Secondary	Change in body thermoregulatory capacity as measured by thermoregulatory sweat testing		baseline, approximately 50 weeks after implantation
Secondary	Change in lean body mass		baseline, approximately 50 weeks after implantation
Secondary	Change in bone density		baseline, approximately 50 weeks after implantation
Secondary	Change in sense of wellbeing as measured by the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire		baseline, approximately 50 weeks after implantation
Secondary	Change in sitting balance via functional reach test		baseline, approximately 50 weeks after implantation
Secondary	Change in spasticity via Ashworth spasticity test		baseline, approximately 50 weeks after implantation
Secondary	Change in ability of performing basic activities of daily life via spinal cord independence measure		baseline, approximately 50 weeks after implantation
Secondary	Change in total body fat		baseline, approximately 50 weeks after implantation
Secondary	Change in bowel function as measured by the Neurogenic Bowel Dysfunction Score questionnaire		baseline, approximately 50 weeks after implantation

External Links

•   Mayo Clinic Clinical Trials