Association Between tDCS and Lokomat Training in Patients With Incomplete Spinal Cord Injury
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The spinal cord injury is identified as the major cause of permanent disability worldwide,
      with the loss of ability to walk being the largest and most devastating of them for these
      patients. Our goal is to analyze the effects of electrical transcranial direct-current
      stimulation (tDCS) combined with gait training with partial body weight support aided by
      robotic device (Lokomat, Hocoma) in the gait of patients with incomplete spinal cord injury
      (SCI). In this stratified randomized double-blind study, the participants will be randomly
      allocated into one of both groups, outpatients (GA) or inpatients (GI), and will receive
      active or placebo tDCS followed by gait training with Lokomat (GA: 3 sessions/week x 10 weeks
      = 30 sessions; GI: 5 sessions/week x 6 weeks = 30 sessions). The functional assessments
      (through clinical and functional scales, assess gait, muscle strength, spasticity, balance
      and pain) and neurophysiological (cortical excitability measured by transcranial magnetic
      stimulation, electroencephalography and functional near-infrared spectroscopy) will be held
      before and after the training period. The functional assessments will be also held after 15
      sessions (intermediate) and after 3 months follow up. The expected result is that patients
      that received the active tDCS presents an improvement over the ground gait after the Lokomat
      training period significantly greater than the placebo group, with relations between
      neurophysiologic, kinematics and functional measurements.
    

Detailed description: 
      The spinal cord injury is identified as the major cause of permanent disability worldwide,
      with the loss of ability to walk being the largest and most devastating of them for these
      patients. Therefore, our goal is to analyze the effects of the treatment with electrical
      transcranial direct-current stimulation (tDCS) associated with gait training with partial
      body weight support aided by robotic device (Lokomat, Hocoma) in the gait of patients with
      incomplete spinal cord injury (SCI) classified as AIS C and D. In this stratified randomized
      double-blind study, the participants will be randomly allocated into one of both groups,
      outpatients (GA) or inpatients (GI), and will receive active or placebo tDCS followed by gait
      training with Lokomat (GA: 3 sessions/week x 10 weeks = 30 sessions; GI: 5 sessions/week x 6
      weeks = 30 sessions). The functional assessments (through clinical and functional scales,
      assess gait, muscle strength, spasticity, balance and pain) and neurophysiological (cortical
      excitability measured by transcranial magnetic stimulation, electroencephalography and
      functional near-infrared spectroscopy) will be held before and after the training period. The
      functional assessments will be also held after 15 sessions (intermediate) and after 3 months
      follow up. The expected result is that patients that received the active (tDCS) presents an
      improvement over the ground gait after the Lokomat training period, significantly greater
      than the placebo group, with positive correlation between neurophysiologic, kinematics and
      functional measurements.
    

Intervention name(s): Outpatient active group; Outpatient placebo group; Inpatient active group; Inpatient placebo group
Intervention type(s): Device; Device; Device; Device
Intervention description(s): active tDCS during 20 minutes before Lokomat training for outpatients; placebo tDCS during 20 minutes before Lokomat training for outpatients; active tDCS during 20 minutes before Lokomat training for inpatients; placebo tDCS during 20 minutes before Lokomat training for inpatients
Other intervention name(s): tDCS active; tDCS placebo; tDCS active; tDCS placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Spinal Cord Injuries; gait training; robotic; Lokomat; Transcranial Magnetic Stimulation; transcranial direct-current stimulation; Electroencephalography; Functional near-infrared spectroscopy