Spinal Cord Injuries, Tetraplegia
Conditions
Brief summary
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
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.
Interventions
OTHERtranscranial direct current stimulation
Transcranial direct current stimulation, a form of neuromodulation that uses a low direct current delivered via sponge electrodes on the head.
OTHERsham transcranial direct current stimulation
an inactive or placebo version of transcranial direct current stimulation placed on the head via sponge electrodes.
Sponsors
New York State Spinal Cord Injury Research Board (SCIRB)
Burke Medical Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
All participants, raters, and experimenters will be blinded to treatment allocation.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Box and Blocks Test | Baseline, immediately post-intervention, and 1 month follow up | A timed functional test to determine gross manual dexterity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spinal Cord Independence Measure (SCIM III) | Baseline, immediately post-intervention, and 1 month follow up | Evaluates patient's ability to complete activities of daily living; 19 questions in 3 domains; Scored 0 (severely impaired) -100 (independent) |
| Modified Ashworth Scale | Baseline, immediately post-intervention, and 1 month follow up | Measures spasticity; Each muscle assessed is scored between 0-4, with 4 indicating rigid limbs or very severely affected. |
| Upper Extremity Motor Score | Baseline, immediately post-intervention, and 1 month follow up | Manual muscle test of arm muscles; Score range from 0= no movement to 5= normal movement. |
| Questionnaire of von Korff et al Grading the Severity of Chronic Pain | Baseline, immediately post-intervention, and 1 month follow up | Self-evaluation of pain; 7 questions in total; 0= no pain, 100= severe pain |
| Quadraplegia Index of Function- Short Form | Baseline, immediately post-intervention, and 1 month follow up | Global function scale; 6 items dcored on a 5 point scale from 0 (dependent) to 4 (independent). |
| Nine Hole Peg Test | Baseline, immediately post-intervention, and 1 month follow up | Timed measure of fine motor skills and dexterity |
Countries
United States
Outcome results
None listed