Combined Robotic Training and tDCS in Chronic SCI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Hand Function in Chronic SCI With Combined Robotic Training and tDCS

Conditions
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Spinal Cord Injuries, Tetraplegia

Intervention / Treatment
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* Other: transcranial direct current stimulation
* Other: sham transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tetraplegia (cervical lesion) with some degree of motor dysfunction in the hand (ability to pick up at least 1 block on the Box and Blocks Test) Motor incomplete lesion (measured by the ASIA Impairment Scale, B, C, D) Chronic lesion (>6 months after the injury) Exclusion Criteria: Motor and sensory complete lesion (AIS A) Presence of potential risk factor for brain stimulation (TMS and tDCS): history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull History of head trauma and/or cognitive deficit Medically unstable

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active tDCS<br>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. | Other: transcranial direct current stimulation<br>* Transcranial direct current stimulation, a form of neuromodulation that uses a low direct current delivered via sponge electrodes on the head.<br>|
| Sham Comparator: Sham tDCS<br>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. | Other: sham transcranial direct current stimulation<br>* an inactive or placebo version of transcranial direct current stimulation placed on the head via sponge electrodes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |