Clinical trial NCT03555838: Combined Robotic Training and tDCS in Chronic SCI
Official title: Improving Hand Function in Chronic SCI With Combined Robotic Training and tDCS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Spinal Cord Injuries
Tetraplegia
Lead sponsor: Burke Medical Research Institute
Sponsor class: OTHER
Collaborators: name: New York State Spinal Cord Injury Research Board (SCIRB)
First posted: 2018-06-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Box and Blocks Test
timeFrame: Baseline, immediately post-intervention, and 1 month follow up
Secondary outcomes:
measure: Upper Extremity Motor Score
timeFrame: Baseline, immediately post-intervention, and 1 month follow up
measure: Spinal Cord Independence Measure (SCIM III)
timeFrame: Baseline, immediately post-intervention, and 1 month follow up
measure: Modified Ashworth Scale
timeFrame: Baseline, immediately post-intervention, and 1 month follow up
measure: Nine Hole Peg Test
timeFrame: Baseline, immediately post-intervention, and 1 month follow up
measure: Questionnaire of von Korff et al Grading the Severity of Chronic Pain
timeFrame: Baseline, immediately post-intervention, and 1 month follow up
measure: Quadraplegia Index of Function- Short Form
timeFrame: Baseline, immediately post-intervention, and 1 month follow up
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Medical Research Institute
state: New York
Study officials:
References: