Back to resultsShort-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI
Primary Purpose
Paraplegia, Tetraplegia, Paralysis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous epidural electrical spinal stimulation
Transcutaneous electrical spinal stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Paraplegia
Eligibility Criteria
Inclusion Criteria:
- Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae (T10)
- American Spinal Injury Association grading scale of A-D (2 from each) below the level of SCI
- Intact spinal reflexes below the level of SCI
- At least 1-year post-SCI
- At least 22 years of age
- Willing to use medically acceptable methods of contraception, if female and of child-bearing potential
Exclusion Criteria:
- Currently a prison inmate, or awaiting trial, related to criminal activity
- Pregnancy at the time of enrollment
- History of chronic and/or treatment resistant urinary tract infection
- Unhealed decubitus ulcer
- Unhealed skeletal fracture
- Untreated clinical diagnosis of depression
- Undergoing, or planning to undergo, diathermy treatment
- Active participation in another interventional clinical trial
- Presence of conditions or disorders which require MRI monitoring
- A history of coagulopathy or other significant cardiac or medical risk factors for surgery
- Current use of a ventilator
- Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
- History of frequent hypotension characterized by light headedness, or loss of consciousness
- History of frequent hypertension characterized by headache, or bradycardia
- History of frequent, severe, autonomic dysreflexia
- Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Percutaneous Epidural Stimulation
Transcutaneous Epidural Stimulation
Arm Description
Epidural spinal stimulation will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of epidural stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
Transcutaneous spinal stimulation will be delivered via skin surface-level electrodes during rehabilitation. The effects of transcutaneous stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
Outcomes
Primary Outcome Measures
Kinematics
Change in measurements of joint angles, measured in degrees.
Electromyography
Change in voltage measurements in major muscle groups below the level of injury.
Foot pressure
Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.
Somatosensory evoked potentials
Measurements of change in voltage in the conduction of electricity through the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, using surface electrodes.
Transcranial magnetic stimulation motor evoked potentials
Measurement of change in voltage required to elicit muscle responses in muscle groups known to elicit optimal motor evoked potential responses, both above and below the level of injury.
Injury severity: International Standards for Neurological Classification of Spinal Cord Injury
Change in measurements of impairment of sensory and motor functions using the American Spinal Injury Association Impairment Scale (AISA Scale). Individuals are classified from A" (complete spinal cord injury) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Results are summed to produce overall sensory and motor scores and are used in combination with evaluation of anal sensory and motor function as a basis for the determination of AIS classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against significant resistance) for each myotome. Upper Extremity Motor Subscores and Lower Extremity Motor Subscores are each scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of anal sensation and voluntary anal contraction are assessed as a yes/no.
Patient-reported bowel function
Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms.
Patient-reported bladder function
Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms.
Male patient-reported sexual function (1)
Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction.
Male patient-reported sexual function (2)
Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction.
Female patient-reported sexual function
Measurement of change in sexual function using the Female Sexual Function Index (FSFI). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better sexual function, and totaled for a score which categorizes severity of sexual dysfunction.
Spasticity
Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms.
Neurostimulation user experience
Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym.
Overground ambulation [as appropriate to the subject]
Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.
Trunk stability
Changes in trunk stability based on stable forward reach measured in centimeters, with a greater distance of forward reach characterizing greater trunk stability.
Neurostimulator lead location and migration [Epidural group only]
Evaluation of current array location via CT.
Bladder function testing
Change in measurements of bladder function utilizing a urodynamic test consisting of a filling phase and a voiding phase cystometrogram along with perineal patch muscle electromyography.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05095454
Brief Title
Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI
Official Title
A Pilot Study to Compare Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 4, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
March 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kristin Zhao, PhD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.
Detailed Description
The purpose of this study is to compare spinal motor nerve response to electrical stimulation delivered directly to the epidural space, and delivered through the skin (transcutaneously), and to measure any changes in motor performance over the course of about 5 months, during and after using one of the two types of stimulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraplegia, Tetraplegia, Paralysis, Quadraplegia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous Epidural Stimulation
Arm Type
Experimental
Arm Description
Epidural spinal stimulation will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of epidural stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
Arm Title
Transcutaneous Epidural Stimulation
Arm Type
Experimental
Arm Description
Transcutaneous spinal stimulation will be delivered via skin surface-level electrodes during rehabilitation. The effects of transcutaneous stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
Intervention Type
Device
Intervention Name(s)
Percutaneous epidural electrical spinal stimulation
Intervention Description
Abbott percutaneous trial lead for epidural neurostimulation (Model 3086)
Ripple Neuromed Nomad Neurostimulation System
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical spinal stimulation
Intervention Description
Digitimer DS8R Bipolar Constant Current Stimulator
Primary Outcome Measure Information:
Title
Kinematics
Description
Change in measurements of joint angles, measured in degrees.
Time Frame
Through study completion; an average of 5 months.
Title
Electromyography
Description
Change in voltage measurements in major muscle groups below the level of injury.
Time Frame
Through study completion; an average of 5 months.
Title
Foot pressure
Description
Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.
Time Frame
Through study completion; an average of 5 months.
Title
Somatosensory evoked potentials
Description
Measurements of change in voltage in the conduction of electricity through the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, using surface electrodes.
Time Frame
Through study completion; an average of 5 months.
Title
Transcranial magnetic stimulation motor evoked potentials
Description
Measurement of change in voltage required to elicit muscle responses in muscle groups known to elicit optimal motor evoked potential responses, both above and below the level of injury.
Time Frame
Through study completion; an average of 5 months.
Title
Injury severity: International Standards for Neurological Classification of Spinal Cord Injury
Description
Change in measurements of impairment of sensory and motor functions using the American Spinal Injury Association Impairment Scale (AISA Scale). Individuals are classified from A" (complete spinal cord injury) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Results are summed to produce overall sensory and motor scores and are used in combination with evaluation of anal sensory and motor function as a basis for the determination of AIS classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against significant resistance) for each myotome. Upper Extremity Motor Subscores and Lower Extremity Motor Subscores are each scored from 0 to 50; the ASIA Motor Score is scored from 0 to 100. The presence of anal sensation and voluntary anal contraction are assessed as a yes/no.
Time Frame
Through study completion; an average of 5 months.
Title
Patient-reported bowel function
Description
Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms.
Time Frame
Through study completion; an average of 5 months.
Title
Patient-reported bladder function
Description
Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms.
Time Frame
Through study completion; an average of 5 months.
Title
Male patient-reported sexual function (1)
Description
Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction.
Time Frame
Through study completion; an average of 5 months.
Title
Male patient-reported sexual function (2)
Description
Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction.
Time Frame
Through study completion; an average of 5 months.
Title
Female patient-reported sexual function
Description
Measurement of change in sexual function using the Female Sexual Function Index (FSFI). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better sexual function, and totaled for a score which categorizes severity of sexual dysfunction.
Time Frame
Through study completion; an average of 5 months.
Title
Spasticity
Description
Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms.
Time Frame
Through study completion; an average of 5 months.
Title
Neurostimulation user experience
Description
Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym.
Time Frame
End of intervention.
Title
Overground ambulation [as appropriate to the subject]
Description
Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.
Time Frame
Through intervention completion; an average of 4 weeks.
Title
Trunk stability
Description
Changes in trunk stability based on stable forward reach measured in centimeters, with a greater distance of forward reach characterizing greater trunk stability.
Time Frame
Through study completion; an average of 5 months.
Title
Neurostimulator lead location and migration [Epidural group only]
Description
Evaluation of current array location via CT.
Time Frame
Beginning of study, prior to initiating intervention; End of 4 weeks of intervention.
Title
Bladder function testing
Description
Change in measurements of bladder function utilizing a urodynamic test consisting of a filling phase and a voiding phase cystometrogram along with perineal patch muscle electromyography.
Time Frame
Beginning of study, prior to initiating intervention; End of 4 weeks of intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae (T10)
American Spinal Injury Association grading scale of A-D (2 from each) below the level of SCI
Intact spinal reflexes below the level of SCI
At least 1-year post-SCI
At least 22 years of age
Willing to use medically acceptable methods of contraception, if female and of child-bearing potential
Exclusion Criteria:
Currently a prison inmate, or awaiting trial, related to criminal activity
Pregnancy at the time of enrollment
History of chronic and/or treatment resistant urinary tract infection
Unhealed decubitus ulcer
Unhealed skeletal fracture
Untreated clinical diagnosis of depression
Undergoing, or planning to undergo, diathermy treatment
Active participation in another interventional clinical trial
Presence of conditions or disorders which require MRI monitoring
A history of coagulopathy or other significant cardiac or medical risk factors for surgery
Current use of a ventilator
Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
History of frequent hypotension characterized by light headedness, or loss of consciousness
History of frequent hypertension characterized by headache, or bradycardia
History of frequent, severe, autonomic dysreflexia
Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin D Zhao, Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI
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