Clinical trial NCT02562001: Association Between tDCS and Lokomat Training in Patients With Incomplete Spinal Cord Injury
Official title: Association of Transcranial Direct Current Stimulation (tDCS) With Gait Training With Partial Body Weight Support on the Robotic Device (Lokomat) for Treatment of Patients With Incomplete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injuries
gait training
robotic
Lokomat
Transcranial Magnetic Stimulation
transcranial direct-current stimulation
Electroencephalography
Functional near-infrared spectroscopy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: A. Change in the Walk Index for Spinal Cord Injury, WISCI II
timeFrame: 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:
measure: American Spinal Injury Association Impairment Scale - ASIA
timeFrame: pre (before treatment) [t0]
measure: Change in the (Wechsler Adult Intelligence Scale - WASI 2014)
timeFrame: 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]
measure: Change in the Ashworth Modified Scale
timeFrame: 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]
measure: Change in the Berg Balance Test
timeFrame: 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]
measure: Change in the 10 meters Walking Test and 6 Minutes Walking test
timeFrame: 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]
measure: Change in the Time Up and Go Test - TUG
timeFrame: 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]
measure: Change in the Short Form - 36 Quality of Life Test - SF 36
timeFrame: 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]
measure: Change in the Spinal Cord Independence Measure - SCIM
timeFrame: 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]
measure: Change in the Lower Extremity Isokinetic Dynamometry
timeFrame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
measure: Change in the Visual Analogic Scale - VAS
timeFrame: 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]
measure: Change in the Brazilian version of the McGill Pain Questionnaire
timeFrame: 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]
measure: Change in the Pressure Algometer
timeFrame: 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]
measure: Change in the Conditioned Pain Modulation - CPM
timeFrame: 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]
measure: Change in the Pain-Related Self-Statements Scale - Catastrophizing Subscale (PRSS-Catastrophizing)
timeFrame: 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]
measure: Change in the Hospital Anxiety and Depression Scale - HAD
timeFrame: 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]
measure: Change in the Beck Depression Inventory
timeFrame: 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]
measure: Change in the Patient Health Questionnaire 9 - PHQ 9
timeFrame: 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]
measure: Change in the Transcranial Magnetic Stimulation
timeFrame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
measure: Change in the Functional Near-Infrared Spectroscopy - fNIRS 16 optodes (48 channels)
timeFrame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
measure: Change in the Electroencephalography
timeFrame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Linamara Battistella, Md PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pai MYB, Terranova TT, Simis M, Fregni F, Battistella LR. The Combined Use of Transcranial Direct Current Stimulation and Robotic Therapy for the Upper Limb. J Vis Exp. 2018 Sep 23;(139):58495. doi: 10.3791/58495.
citation: Simis M, Uygur-Kucukseymen E, Pacheco-Barrios K, Battistella LR, Fregni F. Beta-band oscillations as a biomarker of gait recovery in spinal cord injury patients: A quantitative electroencephalography analysis. Clin Neurophysiol. 2020 Aug;131(8):1806-1814. doi: 10.1016/j.clinph.2020.04.166. Epub 2020 May 22.