Transcutaneous Spinal Cord Stimulation and Robotic Therapy
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Lumbosacral spinal stimulation activates the neural network involved in the control of
      locomotion at the spinal level. However, its effects are limited to the production of robust
      rhythmic patterns of alternating movement, being currently in the absence of therapeutic
      value. On the other hand, the use of robotic technology for gait rehabilitation has
      experienced significant growth during the last years and its clinical efficacy is similar to
      others traditional interventions.
    

Detailed description: 
      Spinal cord injury (SCI) often results in complete or partial paralysis below the level of
      lesion, having a profound physical, psychological and socioeconomic impact on the affected
      person's life. Between the different approaches for the rehabilitation of SCI, we can find
      robot therapy. Robot-assisted gait training has emerged as a promising therapy for improving
      walking ability, balance and motor function in neurological patients. The underlying
      principle of this therapy is based on the execution of repetitive and task-specific training
      able to generate appropriate afferent inputs, activating the central pattern generators in
      the lumbosacral spinal cord. Another novel therapy is the use of transcutaneous spinal cord
      stimulation (tSCS), applied through self-adhesive electrodes in the skin. tSCS activates
      similar mechanisms than epidural stimulation and is able to stimulate the spinal locomotor
      circuits in SCI patients. It allows the activation of rhythmic, flexo-extension movements in
      the paralyzed lower limbs.

      The aim of this study is to analyze the feasibility, safety and efectiveness of a program of
      20 sessions of 30 Hz-tSCS applied over T11-12 intervertebral space combined with Lokomat
      training in patients with incomplete SCI.
    

Intervention name(s): Active tSCS and Lokomat; Sham tSCS and Lokomat
Intervention type(s): Device; Device
Intervention description(s): A symmetrical biphasic 30 Hz current of 1 ms pulse-width with an electro-stimulator will be applied.
For the stimulation intensity, the maximum intensity tolerated by the patient will be selected. The intensity will be increased in case of habituation to the current.; The protocol and device of sham tSCS combined with Lokomat will be the same as active tSCS except for the stimulus intensity, which will be set at the sensory threshold, maintained for 30 seconds and then slowly will be decreased to zero, being this intensity maintained for the remaining 20 minutes of stimulation.
Other intervention name(s): Experimental; Controlled
Intervention MeSH terms: Trans-sodium crocetinate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a double-blind, randomized, controlled clinical trial.
There will be two groups:
Group A (n=15): tSCS combined with Lokomat Group B (n=15): Sham-tSCS combined with Lokomat
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuromodulation; Spinal cord injury; Robotics; Transcutaneous spinal cord stimulation; Lokomat