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| Name | Class |
|---|---|
| New York State Spinal Cord Injury Research Board (SCIRB) | UNKNOWN |
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The purpose of this study is to establish the value of combined non-invasive stimulation (tDCS) and behavioral training (robotics) in SCI rehabilitation, and understand the mechanisms of this interaction and its relationship to functional outcome. The investigators hypothesize that supplementary tDCS will augment the functional improvement from robot-training, in chronic SCI.
Study design: Using a within-subjects repeated measures design, up to 40 SCI participants will be randomized to receive 6-week hand robotic training preceded by 20 min anodal 2mA tDCS or sham (3 sessions/week, 18 sessions total). Clinical and functional scales, robotic kinematics and neurophysiological data (TMS evaluation) will be collected before and after the combined intervention period, and a month later (pre, post and follow up evaluations). Randomization will be done using a randomized block design with a block size of 2. All participants, raters, and experimenters will be blinded to treatment allocation.
AIM 1. To determine whether combining non-invasive brain stimulation (tDCS) and behavioral training (robotics) in SCI can lead to functional improvement. The investigators hypothesize that the group receiving the real stimulation will obtain a greater clinical improvement in hand motor function. Using a within subjects repeated measures design, baseline clinical hand function (Box and Blocks test) will be compared to post 6-week robotic training intervention, and then a month later (follow up), each session preceded by real (2mA anodal M1) or sham tDCS.
AIM 2. To examine the kinematic changes (from robotic measures) associated with the combined training. Quantitative measurements obtained from robotics are highly sensitive, precise and reliable. The investigators predict an enhancement of motor performance in all participants, measured by 5 key parameters: mean speed, peak speed, smoothness, aim and deviation; with greater improvements in the intervention group receiving the pre-conditioning effect of transcranial stimulation. These data will identify features of motor control that underlie improvements in clinical function, when comparing the two intervention groups.
AIM 3. To identify and compare the neurophysiological mechanisms (by TMS) associated with the combined training. The relationship between clinical improvement in neurophysiological measures pertaining to robotic motor training alone and combined with tDCS will be assessed. Measuring changes in MEP amplitude of hand muscles before and after the training will establish a) the plasticity associated with training alone and with supplementary brain stimulation, b) the neurophysiological characteristics of patients who respond better to the training. By understanding how brain excitability changes underpin motor dysfunction, and motor recovery, interventions can be more effectively prescribed and prognoses established.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Participants in this arm will receive 20 minutes of 2 mA transcranial direct current stimulation over the primary motor cortex of the more affected arm prior to robotic training. |
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| Sham tDCS | Sham Comparator | Participants in this arm will receive 20 minutes of sham transcranial direct current stimulation over the primary motor cortex of the more affected arm prior to robotic training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | Other | Transcranial direct current stimulation, a form of neuromodulation that uses a low direct current delivered via sponge electrodes on the head. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Box and Blocks Test | A timed functional test to determine gross manual dexterity | Baseline, immediately post-intervention, and 1 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Extremity Motor Score | Manual muscle test of arm muscles; Score range from 0= no movement to 5= normal movement. | Baseline, immediately post-intervention, and 1 month follow up |
| Spinal Cord Independence Measure (SCIM III) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Medical Research Institute | White Plains | New York | 10605 | United States |
There is no plan to make individual participant data available to other researchers at this time.
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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Within-subjects repeated measures design up to 40 SCI participants will be randomized to receive 6-week hand robotic training preceded by 20 min anodal 2mA tDCS or sham (3 sessions/week, 18 sessions total). Randomization will be done using a randomized block design with a block size of 2.
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All participants, raters, and experimenters will be blinded to treatment allocation.
| sham transcranial direct current stimulation | Other | an inactive or placebo version of transcranial direct current stimulation placed on the head via sponge electrodes. |
|
Evaluates patient's ability to complete activities of daily living; 19 questions in 3 domains; Scored 0 (severely impaired) -100 (independent)
| Baseline, immediately post-intervention, and 1 month follow up |
| Modified Ashworth Scale | Measures spasticity; Each muscle assessed is scored between 0-4, with 4 indicating rigid limbs or very severely affected. | Baseline, immediately post-intervention, and 1 month follow up |
| Nine Hole Peg Test | Timed measure of fine motor skills and dexterity | Baseline, immediately post-intervention, and 1 month follow up |
| Questionnaire of von Korff et al Grading the Severity of Chronic Pain | Self-evaluation of pain; 7 questions in total; 0= no pain, 100= severe pain | Baseline, immediately post-intervention, and 1 month follow up |
| Quadraplegia Index of Function- Short Form | Global function scale; 6 items dcored on a 5 point scale from 0 (dependent) to 4 (independent). | Baseline, immediately post-intervention, and 1 month follow up |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |