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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| California Institute of Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Grp#1: Training w/ and w/o Stim | Other | 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. |
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| Grp#2: Training+Single Site Stimulation | Active Comparator | 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 |
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| Grp #3: Training + Two Site Stimualtion | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Spinal Cord Stimulation | Device | A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord. |
| 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 |
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Inclusion Criteria: ASIA C
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victor R Edgerton, PhD | University of California, Los Angeles | Study Chair |
| Nicholas Terrafranca, DPM | NeuroEnabling Technologies, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90095 | United States | ||
| Strides SCI Functional Fitness |
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| ID | Term |
|---|---|
| D010243 | Paralysis |
| D013119 | Spinal Cord Injuries |
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| San Juan Capistrano |
| California |
| 92675 |
| United States |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |