Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

Study Overview
=================
Brief Summary
-----------------
This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury.

Detailed Description
-----------------
This study is to determine if non-invasive electrical stimulation of the spinal cord can help improve hand and arm function in people with paralysis who suffered a cervical spinal cord injury. The investigators hypothesize that this stimulation can revive spared function in the spinal cord of individuals who are clinically paralyzed, but who have some remaining connections between the brain and spinal cord. Our research has demonstrated that modifying the activation state of the spinal cord 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 gain FDA approval.

Official Title
-----------------
Restoring Arm and Hand Function With Non-invasive Spinal Stimulation

Conditions
-----------------
Paralysis, Spinal Cord Injury

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASIA C Spinal cord injury 1 or more years prior Non progressive SCI at C7 or higher Half of key muscles below neurological level having a motor score of less than 2/5 Ability to commit to home exercises and 12 week participation Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in upper 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 upper 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 12 week study period No current anti-spasticity regimen Must not have received botox injections in the prior six months Be unable to use upper 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Grp#1: Training w/ and w/o Stim<br>Control- Group #1: 4 weeks training without any transcutaneous electrical stimulation followed by 2 weeks of training plus transcutaneous electrical spinal cord stimulation applied to one or two locations of the cervical (neck) region of the spinal cord. | Device: Transcutaneous Electrical Spinal Cord Stimulation<br>* A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.<br>* Other names: Prototype device;|
| Active Comparator: Grp#2: Training+Single Site Stimulation<br>Group #2: Four weeks of training plus transcutaneous electrical spinal cord stimulation applied to one location along the cervical (neck) region of the spinal cord; followed by 2 weeks of training without stimulation | Device: Transcutaneous Electrical Spinal Cord Stimulation<br>* A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.<br>* Other names: Prototype device;|
| Active Comparator: Grp #3: Training + Two Site Stimualtion<br>Group #3: Four weeks of training plus transcutaneous electrical spinal cord stimulation applied to two locations along the cervical (neck) region of the spinal cord; followed by 2 weeks of training without stimulation | Device: Transcutaneous Electrical Spinal Cord Stimulation<br>* A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.<br>* Other names: Prototype device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in sensorimotor function in arms and hands | Subjects will be tested by several measures of sensory and motor function, as well as self-assessments regarding quality of life and independence, at the beginning of the study and at each testing session. These tests include: American Spinal Injury Association (ASIA) scoring system. Box and block CUE (Capabilities of Upper Extremity) GRASSP (Graded Redefined Assessment of Strength, Sensibility and Prehension) SCIM (Spinal Cord Independence Measure) Ashworth Spasticity scale: Penn Spasm Frequency VAS (Visual Analog Scale) for Spasticity) | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spinal cord injury, quadriplegia, tetraplegia, stimulation