Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI

Tetraplegia Clinical Trial

Official title:

A Pilot Study to Compare Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095454
• Other study ID #: 21-006340
• Status: Completed
• Phase: N/A
• Start date: March 4, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Paralysis
• Paraplegia
• Quadraplegia
• Quadriplegia
• Tetraplegia

Intervention

Device:
• Percutaneous epidural electrical spinal stimulation
Abbott percutaneous trial lead for epidural neurostimulation (Model 3086) Ripple Neuromed Nomad Neurostimulation System
• Transcutaneous electrical spinal stimulation
Digitimer DS8R Bipolar Constant Current Stimulator

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Kristin Zhao, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematics	Change in measurements of joint angles, measured in degrees.	Through study completion; an average of 5 months.
Primary	Electromyography	Change in voltage measurements in major muscle groups below the level of injury.	Through study completion; an average of 5 months.
Primary	Foot pressure	Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.	Through study completion; an average of 5 months.
Primary	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.	Through study completion; an average of 5 months.
Primary	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.	Through study completion; an average of 5 months.
Primary	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.	Through study completion; an average of 5 months.
Primary	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.	Through study completion; an average of 5 months.
Primary	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.	Through study completion; an average of 5 months.
Primary	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.	Through study completion; an average of 5 months.
Primary	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.	Through study completion; an average of 5 months.
Primary	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.	Through study completion; an average of 5 months.
Primary	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.	Through study completion; an average of 5 months.
Primary	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.	End of intervention.
Primary	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.	Through intervention completion; an average of 4 weeks.
Primary	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.	Through study completion; an average of 5 months.
Primary	Neurostimulator lead location and migration [Epidural group only]	Evaluation of current array location via CT.	Beginning of study, prior to initiating intervention; End of 4 weeks of intervention.
Primary	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.	Beginning of study, prior to initiating intervention; End of 4 weeks of intervention.