Association Between tDCS and Lokomat Training in Patients With Incomplete Spinal Cord Injury

N/ACompletedNCT02562001

University of Sao Paulo General Hospital42 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical and radiological diagnosis of incomplete spinal cord injury of traumatic origin; * 1 to 36 months of lesion; * ASIA C and D; * Stable clinical status; * Cognitive function preserved in order to understand and execute the experiment and follow the instructions (Wechsler Adult Intelligence Scale - WASI 2014); * Written informed consent; * Tolerance to sit upright for at least 1 hour. Exclusion Criteria: * Traumatic brain injury history, stroke, epilepsy and/or any other previous or concomitant neurological conditions to spinal cord injury; * Presence of progressive neurodegenerative disease; * Previous orthopedic problems (eg osteoarthritis, joint deformities); * Member hypertonic (grade \> 3 on the modified Ashworth scale); * Active/passive joint range of motion limitations; * Irreversible muscle contractures; * Lack of physical resistance during proposed physical training; * Disabling fatigue; * Body weight \> 150 Kg; * Osteoporosis with pathological fracture risk; * Asymmetry in the lower limbs \> 2 cm; * Skin lesions and / or pressure ulcer in areas where the orthosis of Lokomat will press; * Any other exclusion criteria established by medical decision. Exclusion criteria for TMS: Skin lesions in the stimulation site; presence of electric, magnetic or mechanically activated implant (including cardiac pacemakers); intracerebral vascular clip or any other electrically sensitive device; pregnancy; metal in any part of the head; history of epilepsy resistant to medication; history of seizures or loss of consciousness not clarified and / or unaccompanied by a doctor. Exclusion criteria for Lokomat: Cardiac pacemaker; unstable angina or other decompensated heart disease; decompensated chronic obstructive pulmonary disease; unchecked autonomic dysreflexia that hinders Lokomat training; unhealed fracture of the bones of the lower limbs; tracheostomy; deformities and stiffness of the hip joint, knee ( ≥ 20° flexion) and ankle ( ≥ 10° plantar flexion).

Outcomes

Primary Outcomes

A. Change in the Walk Index for Spinal Cord Injury, WISCI II

Time frame: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]

Secondary Outcomes

American Spinal Injury Association Impairment Scale - ASIA

Time frame: pre (before treatment) [t0]

Change in the (Wechsler Adult Intelligence Scale - WASI 2014)

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]

Change in the Ashworth Modified Scale

Time frame: pre (before treatment) [t0],inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]

Change in the Berg Balance Test

Time frame: pre (before treatment) [t0],inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]

Change in the 10 meters Walking Test and 6 Minutes Walking test

Change in the Time Up and Go Test - TUG

Change in the Short Form - 36 Quality of Life Test - SF 36

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]

Change in the Spinal Cord Independence Measure - SCIM

Change in the Lower Extremity Isokinetic Dynamometry

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]

Change in the Visual Analogic Scale - VAS

Change in the Brazilian version of the McGill Pain Questionnaire

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]

Change in the Pressure Algometer

Change in the Conditioned Pain Modulation - CPM

Change in the Pain-Related Self-Statements Scale - Catastrophizing Subscale (PRSS-Catastrophizing)

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]

Change in the Hospital Anxiety and Depression Scale - HAD

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]

Change in the Beck Depression Inventory

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]

Change in the Patient Health Questionnaire 9 - PHQ 9

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]

Change in the Transcranial Magnetic Stimulation

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]

Change in the Functional Near-Infrared Spectroscopy - fNIRS 16 optodes (48 channels)

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]

Change in the Electroencephalography

Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]

Association Between tDCS and Lokomat Training in Patients With Incomplete Spinal Cord Injury

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes