Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Transcutaneous and Epidural Spinal Stimulation for Improving Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04043715
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
U.S. National Science Foundation
Information provided by (Responsible Party):
Rajiv Saigal, University of Washington

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries Device: Transcutaneous spinal stimulation Device: Epidural spinal stimulation Not Applicable

Detailed Description:

The purpose of this study is to determine the optimal method for delivering spinal stimulation to improve walking in people with incomplete spinal cord injury. By directly comparing non-invasive transcutaneous (TransQ) stimulation with implanted epidural stimulation, investigators hope to guide the field toward the most beneficial method for restoration of lower extremity function. In addition, the investigators may identify subgroups of people that respond better to each type of stimulation, informing personalized treatment for people with different types of spinal cord injury. The research team will explore the following specific aims:

Aim 1: Evaluate the improvements in lower extremity and autonomic function via transcutaneous spinal stimulation and intensive physical therapy for people with chronic SCI.

Aim 2: Quantify additional improvements in lower extremity and autonomic function via epidural spinal stimulation and intensive physical therapy for people with chronic SCI.

The investigators will test the hypothesis that epidural stimulation leads to greater improvements than an equal dose of transcutaneous stimulation. To compare these 2 stimulation methods the study team will evaluate voluntary control of muscle activity via EMG and kinematic parameters of locomotion, as well as improvements in bladder and other autonomic functions and overall quality of life.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spinal Stimulation for Standing & Walking; Comparison of Transcutaneous & Epidural Stimulation
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Comparison of transcutaneous & epidural stimulation
Comparison of transcutaneous vs epidural electrical stimulation
Device: Transcutaneous spinal stimulation
Physical therapy to improve standing and walking
Other Name: Physical Therapy

Device: Epidural spinal stimulation
Physical therapy to improve standing and walking
Other Name: Physical Therapy




Primary Outcome Measures :
  1. Neuromuscular Recovery Scale [ Time Frame: 8-11 months ]
    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.


Secondary Outcome Measures :
  1. International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination [ Time Frame: 8-11 months ]
    Standard neurologic examination that is routinely used to determine the levels and severity of spinal cord injury. Includes manual muscle strength testing and dermatomal light touch and pin prick sensory examination.

  2. Somatosensory evoked potentials [ Time Frame: 8-11 months ]
    Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist. The amplitude of the response is reported in micro-volts.

  3. Motor evoked potentials - Latency [ Time Frame: 8-11 months ]
    Measurement of latency of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The latency of the response is reported in micro-seconds.

  4. Motor evoked potentials - Amplitude [ Time Frame: 8-11 months ]
    Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The amplitude of the response is reported in micro-volts.

  5. Berg Balance Test [ Time Frame: 8-11 months ]
    Measurement of balance in standing and sitting. The balance score consists of 14 items and is reported in the scale of 56 (each items are score in 0-4).

  6. Six-minute walk test [ Time Frame: 8-11 months ]
    Measurement of walking ability. The distance is reported in meter.

  7. Ten-minute walk test [ Time Frame: 8-11 months ]
    Measurement of walking ability. The walking speed is reported in meter per second.

  8. Kinetic and kinematic gait analysis using 3D camera system - angle [ Time Frame: 8-11 months ]
    Measurement of leg function and walking ability. Joint angle is reported in degree angle.

  9. Kinetic and kinematic gait analysis using 3D camera system - velocity [ Time Frame: 8-11 months ]
    Measurement of leg function and walking ability. Velocity is reported in meter per second.

  10. Electromyography recording of LE and trunk muscles [ Time Frame: 8-11 months ]
    Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.

  11. Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire [ Time Frame: 8-11 months ]
    Patient reported quality of life scale. The SCI-QOL consists of 19 item banks, and is reported by T-score comparing the mean of the functional level in the population.

  12. Spinal Cord Injury - Functional Index (SCI-FI) questionnaire [ Time Frame: 8-11 months ]
    Patient reported functional scale. The SCI-QOL consists of 10 item banks, and is reported by T-score comparing the mean of the functional level in the population.

  13. Wartenberg Pendulum Test [ Time Frame: 8-11 months ]
    The Wartenberg Pendulum Test is a measure of spastic hypertonia. Using computer data for number of oscillations and amplitude, values of the Relaxation index (R1 and R2) are calculated and compared to norms.

  14. Walking Index for Spinal Cord Injury II [ Time Frame: 8-11 months ]
    A functional capacity scale designed to measure improvements in ambulation in persons with spinal cord injury, by evaluating the amount of physical assistance, braces or devices required to walk 10 meters.

  15. Neurogenic Bladder Symptom Score [ Time Frame: 8-11 months ]
    24-item questionnaire designed to assess bladder symptoms in patients with neurogenic bladder dysfunction as a result of spinal cord injury, multiple sclerosis, and spinal bifida.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. have a spinal cord injury at least one-year duration;
  2. are between 21 and 70 years of age;
  3. have difficulty with leg functions and mobility in activities of daily living (e.g. walking, transferring surface to surface, standing);
  4. are candidates for an implanted stimulator;
  5. are willing and able to have surgical implantation of the epidural stimulator for the treatment of pain according to the study timeline;
  6. experience chronic pain;
  7. are in stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in lower extremity rehabilitation or testing activities;
  8. are capable of performing simple cued motor tasks;
  9. have the ability to attend 3-5 sessions per week physical therapy sessions and testing activities over three months;
  10. 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;
  11. are volunteering to be involved in this study;
  12. are cleared for gait training by primary physician of the subject;
  13. and have ability to read and speak English

Exclusion Criteria:

  1. have autoimmune etiology of spinal cord dysfunction/injury;
  2. have a history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc.;
  3. have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.);
  4. have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
  5. 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;
  6. have active cancer;
  7. have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention;
  8. have unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses that might interfere with lower extremity rehabilitation or testing activities;
  9. have any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician;
  10. are pregnant;
  11. are dependent on ventilation support;
  12. have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc.);
  13. 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.
  14. have alcohol and/or drug abuse;
  15. have cognitive impairment based on Short Portable Mental Status Questionnaire (SPMSQ) (score >2/10);
  16. are unable to read and/or comprehend the consent form;
  17. are unable to understand the instructions given as part of the study;
  18. have established osteoporosis and are taking medication for osteoporosis treatment;
  19. have bone mineral density T scores ≤ -2.0 in anteroposterior lumbar spine and/or proximal femur measured by DEXA (if participants are clear for other criteria and have not been examined by DEXA at the screening, we will ask participants to undergo DEXA to reveal any risk of weight bearing activity);
  20. have a low-energy fracture history before or after spinal cord injury;
  21. have a history of orthopedic surgery in lower extremities that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, etc.);
  22. have fixed lower extremity joint contractures;
  23. are taller than 80 inches and/or weighs more than 350 pounds (due to the limitation of the experimental equipment such as the body weight support system);
  24. lack the ability to fully comprehend and/or perform study procedures in the investigator's opinion/judgement

Information from the National Library of Medicine

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): NCT04043715


Contacts
Layout table for location contacts
Contact: Soshi Samejima, DPT, MS 206-221-8961 soshis@uw.edu
Contact: Monica Smersh 206-543-6995 msmersh@uw.edu

Locations
Layout table for location information
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Soshi Samejima, DPT, MS    206-221-8961    soshis@uw.edu   
Contact: Rajiv Saigal, MD, PhD       rsaigal@uw.edu   
Sponsors and Collaborators
University of Washington
U.S. National Science Foundation
Investigators
Layout table for investigator information
Principal Investigator: Rajiv Saigal, MD, PhD University of Washington
Layout table for additonal information
Responsible Party: Rajiv Saigal, Assistant Professor, School of Medicine: Neurological Surgery, University of Washington
ClinicalTrials.gov Identifier: NCT04043715    
Other Study ID Numbers: STUDY00004478
EEC-1028725 ( Other Grant/Funding Number: National Science Foundation )
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rajiv Saigal, University of Washington:
transcutaneous spinal stimulation
epidural spinal stimulation
physical therapy
lower extremity
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Cord Injuries
Nervous System Diseases
Central Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries