Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

Study Overview
=================
Brief Summary
-----------------
This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation.

Detailed Description
-----------------
This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation. The investigators hypothesize that this type of stimulation can be used to locate and determine if any spinal (nerve) pathways or connections were spared following a spinal cord injury. We also hypothesize the same stimulation can help revive or recover function to muscles connected to these spared spinal (nerve) pathways in individuals who are clinically paralyzed. Our research has demonstrated that modifying the activation state of the spinal cord after an injury, or awakening the spinal cord, can benefit people with paralysis years after a spinal cord injury. This method and device have not yet been approved by the FDA for the treatment of paralysis and are under investigation. This study if successful will help provide further evidence that could be use to one day to gain FDA approval.

Official Title
-----------------
A Theranostic Tool to Assess and Enable Spared Spinal Motor Function After SCI

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: Transcutaneous Electrical Spinal Cord Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SCI ASIA A, B, C Spinal cord injury 1 or more years prior Non progressive cervical or thoracic SCI Half of key muscles below neurological level having a motor score of less than 2/5 Ability to commit to home exercises and 16 week participation Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in lower extremity rehabilitation or testing activities Not dependent on ventilation support No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary tract infection that might interfere with lower extremity rehabilitation or testing activities No clinically significant depression or ongoing drug abuse Adequate social support network to be able to participate in weekly training and assessment sessions for the duration of the 16 week study period No current anti-spasticity regimen Must not have received botox injections in the prior six months Be unable to use lower extremity for functional tasks Exclusion Criteria: Pregnancy No functional segmental reflexes below the lesion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Grp#1: sham stimulation<br>Group #1: Baseline clinical assessment; followed by two weeks training with no stimulation; then four weeks training + sham Transcutaneous Electrical Spinal Cord Stimulation; followed by repeat clinical assessment; then four weeks training + effective non-sham Transcutaneous Spinal Cord Stimulation; repeat clinical assessment. Secondary outcome measurements: assess ability to stand with and without stimulation using a stance frame support; assess trunk function (core stability) with and without stimulation | Device: Transcutaneous Electrical Spinal Cord Stimulation<br>* A prototype device that non-invasively delivers electrical stimulation to the spinal cord will be used to assess and rehabilitate spared spinal cord function.<br>* Other names: Prototype Device;|
| Active Comparator: Grp#2: Control<br>Group #2: Baseline clinical assessment; followed by two weeks training with no Transcutaneous Electrical Spinal Cord Stimulation; then four weeks training + effective Transcutaneous Electrical Spinal Cord Stimulation; followed by repeat clinical assessment. Secondary outcome measurements: assess ability to stand with and without stimulation using a stance frame support; assess trunk function (core stability) with and without stimulation | Device: Transcutaneous Electrical Spinal Cord Stimulation<br>* A prototype device that non-invasively delivers electrical stimulation to the spinal cord will be used to assess and rehabilitate spared spinal cord function.<br>* Other names: Prototype Device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in sensorimotor function in the lower extremities | Subjects will be tested by several measures of sensory and motor function, as well as self assessments of spasticity, quality of life, and independence. These tests include: American Spinal Injury Association (ASIA) scoring system, Spinal Cord Independence Measure (SCIM), Ashworth Spasticity Scale, Penn Spasm Frequency, Visual Analog Scale (VAS) for Spasticity, Electromyographic (EMG) recordings, Joint angle (goniometer) measures, kinematic analysis. | 10-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to stand independently | Subjects will be evaluated on their core body function and ability to stand | 2-4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal cord injury, Paralysis, Rehabilitation, Assessment, Theranostics