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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|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)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- Six-minute walk test [ Time Frame: 8-11 months ]Measurement of walking ability. The distance is reported in meter.
- Ten-minute walk test [ Time Frame: 8-11 months ]Measurement of walking ability. The walking speed is reported in meter per second.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Soshi Samejima, DPT, MSfirstname.lastname@example.org|
|Contact: Monica Smershemail@example.com|
|Principal Investigator:||Rajiv Saigal, MD, PhD||University of Washington|