Comparison of Transcutaneous and Epidural Spinal Stimulation for Improving Function

NCT04043715 | Withdrawn FDA Device

• 2 other identifiers: STUDY00004478EEC-1028725
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Incomplete spinal cord injuries (SCI) are the most frequent neurologic category, comprising 66.7% of all SCI cases. People with incomplete SCI may retain some ability to move the legs and therefore the capacity to regain walking. Studies that show functional improvement in locomotion via electrical stimulation of lumbosacral circuits suggest that the underlying mechanisms are neuromodulation of lumbosacral spinal cord automaticity and sensory feedback. Both epidural and transcutaneous spinal stimulation are demonstrating exciting potential to improve limb function for people after chronic SCI. Available treatment options for SCI are less than satisfactory and most often do not achieve full restoration of function. Recent experimental results suggest an exciting new approach of using electrical spinal stimulation to enable users to regain control of their weak or paralyzed muscles. Using surgically-implanted electrodes, epidural stimulation results in remarkable improvements of lower extremity function as well as autonomic functions such as bladder function and sexual function. In addition to epidural stimulation, over only the last few years a novel strategy of skin surface electrical spinal stimulation has also demonstrated exciting potential for improving walking function. Using a high-frequency stimulation pulse, current can pass through the skin without discomfort and activate the spinal cord; this results in patterned stepping movements for people without SCI and improved lower extremity function following SCI. This study will directly compare skin-surface transcutaneous stimulation with implanted epidural stimulation for improving lower extremity function.

Conditions

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

Keywords

transcutaneous spinal stimulation; epidural spinal stimulation; physical therapy; lower extremity

Outcome Measures

Primary Outcomes (1)

• Neuromuscular Recovery Scale

  Neuromuscular recovery scale is an assessment for sitting, standing and walking functions based on a comparison to pre-injury performance criteria or how a task was performed one day prior to spinal cord injury and without use of compensation strategies. The items consists of stand retraining, stand adaptability, step retraining, step adaptability, sit, reverse sit up, trunk extension in sitting, sit to stand , stand, walking, and upper limb functions. They are score the scale of 4 based on how close to the function in the pre-injured condition.

  8-11 months

Secondary Outcomes (15)

• International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination

  8-11 months

• Somatosensory evoked potentials

  8-11 months

• Motor evoked potentials - Latency

  8-11 months

• Motor evoked potentials - Amplitude

  8-11 months

• Berg Balance Test

  8-11 months

Study Arms (1)

Comparison of transcutaneous & epidural stimulation

OTHER

Comparison of transcutaneous vs epidural electrical stimulation

Device: Transcutaneous spinal stimulation; Device: Epidural spinal stimulation

Interventions

Transcutaneous spinal stimulation DEVICE

Physical therapy to improve standing and walking

Also known as: Physical Therapy

Comparison of transcutaneous & epidural stimulation

Epidural spinal stimulation DEVICE

Physical therapy to improve standing and walking

Also known as: Physical Therapy

Comparison of transcutaneous & epidural stimulation

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a spinal cord injury at least one-year duration;
• are between 21 and 70 years of age;
• have difficulty with leg functions and mobility in activities of daily living (e.g. walking, transferring surface to surface, standing);
• are candidates for an implanted stimulator;
• are willing and able to have surgical implantation of the epidural stimulator for the treatment of pain according to the study timeline;
• experience chronic pain;
• are in stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in lower extremity rehabilitation or testing activities;
• are capable of performing simple cued motor tasks;
• have the ability to attend 3-5 sessions per week physical therapy sessions and testing activities over three months;
• have adequate social support to be able to participate in assessment sessions occurring between once per week to once per month for up to 9 months;
• are volunteering to be involved in this study;
• are cleared for gait training by primary physician of the subject;
• and have ability to read and speak English

You may not qualify if:

• have autoimmune etiology of spinal cord dysfunction/injury;
• have a history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc.;
• have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.);
• have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
• have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation;
• have active cancer;
• have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention;
• have unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses that might interfere with lower extremity rehabilitation or testing activities;
• have any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician;
• are pregnant;
• are dependent on ventilation support;
• have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc.);
• have depression or anxiety based on the Center for Epidemiologic Studies Depression Scale (CESD) (score \>16/60) and General Anxiety Disorder-7 item Questionnaire (score \>9/21), respectively.
• have alcohol and/or drug abuse;
• have cognitive impairment based on Short Portable Mental Status Questionnaire (SPMSQ) (score \>2/10);

Sponsors & Collaborators

• University of Washington: lead
• U.S. National Science Foundation: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

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

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Rajiv Saigal, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Electrical & Computer Engineering

Model Details: This study will compare the benefits of transcutaneous and epidural stimulation in individuals with SCI through a phased intervention program including: 1) baseline testing, 2) PT only, 3) PT + TransQ stimulation, 4) wash out/recovery, 5) PT + Epidural stimulation, 6) follow-up testing.

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: August 1, 2019
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

US (1)