Regain of Arm and Hand Movements in Cervical Spinal Cord Injury Patients by Means of Spinal Transcutaneous Electrical Neuromodulation Assisted With an Arm Exoskeleton

Patient selection criteria: The study will consist of two populations of patients: Population A will include a total of 10-15 patients with an incomplete cervical lesion (ASIA C and D), and a population B, with 8-15 patients with a complete motor cervical injury (ASIA A and B). Patients from both populations will have ages between 18 and 60 years, with a level of injury between C5 and T1 and with more than 12 months of evolution since the onset of the injury.

Experimental design:

Selected patients from both populations (A and B) will be included in one of the following groups: Group 1: Patients will receive conventional sensory-motor rehabilitation regimen of the upper limb concomitant; Group 2. Patients will receive conventional rehabilitation concomitant with transcutaneous electrical stimulation. Group 3: Patients will have exo-skeleton driven arm rehabilitation concomitant with transcutaneous electrical stimulation. Each session will last 40 minutes and will be done daily during the 6 weeks of evaluation.

Cervical transcutaneous stimulation protocol: Transcutaneous electrical stimulation will be applied by an external set of electrodes, which will be placed on the skin in the midline between the spinous processes of C6 and C8. Two rectangular plates (5.0 x 10.2 cm2) are placed on the skin of the shoulder blades and act as anodes. The electrical stimulation consist of monopolar pulse trains of 1 millisecond duration, released at a frequency of 10 kHz and at an intensity ranging from 80 to 180 mA. Each pulse train is presented at a frequency of 100Hz (ref 8). The stimulation intensity will be adjusted to 90% of the threshold to evoke contractions of the muscles. Rehabilitation of the upper limb. Conventional rehabilitation consists in voluntary, or assisted by a physical therapist, to manually articulate the upper extremities. Patients will perform motor and voluntary rehabilitation of the arms and hands to manipulate objects, performing exercises of grip, endurance and dexterity (ref 9) Robotic upper limb rehabilitation program.

By means of custom-made robotic exo-skeleton patients will move a joystick by a board, following a pattern presented on a television screen. The robot has a sensory feed back system, by which the regain of voluntary movements by the patients will decrease the force exerted by the exo-skeleton to move the arm. Patients will be included in the same number and length of sessions as the conventional rehabilitation regime. Neurological and functional evaluation. To evaluate the effectiveness of the intervention, prior to the initiation of rehabilitation, and once a month until the end of the study, a series of neurological, functional and daily life activities (ref 10) will be performed to evaluate the Effects of spinal stimulation on the motor control of the arms and hands. In addition, prior to the start and the end of each program, motor evoked potentials will be evaluated from the motor cortex and the monoand poly-synaptic reflexes evoked after peripheral nerve stimulation, in order to evaluate the acute and long-term changes in The cortico-medullary and own-medullary connectivity induced by the electrical stimulation.