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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outpatient active group | Experimental | This group will receive active tDCS, combined with Lokomat gait training |
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| Inpatient active group | Experimental | This group will receive active tDCS, combined with Lokomat gait training |
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| Outpatient placebo group | Experimental | This group will receive placebo tDCS, combined with Lokomat gait training |
|
| Inpatient placebo group | Experimental | This group will receive placebo tDCS, combined with Lokomat gait training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Outpatient active group | Device | active tDCS during 20 minutes before Lokomat training for outpatients |
|
| Measure | Description | Time Frame |
|---|---|---|
| A. Change in the Walk Index for Spinal Cord Injury, WISCI II | 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 | Description | Time Frame |
|---|---|---|
| American Spinal Injury Association Impairment Scale - ASIA | pre (before treatment) [t0] | |
| Change in the (Wechsler Adult Intelligence Scale - WASI 2014) | 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] |
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Inclusion Criteria:
Exclusion Criteria:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Linamara Battistella, Md PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina FÃsica e Reabilitação, Hospital das ClÃnicas, Faculdade de Medicina da Universidade de São Paulo | São Paulo | 04116-030 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30295660 | Result | 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. | |
| 32540720 | Result | 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. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| Outpatient placebo group | Device | placebo tDCS during 20 minutes before Lokomat training for outpatients |
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| Inpatient active group | Device | active tDCS during 20 minutes before Lokomat training for inpatients |
|
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| Inpatient placebo group | Device | placebo tDCS during 20 minutes before Lokomat training for inpatients |
|
|
| Change in the Ashworth Modified Scale | 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 | 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 | 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 Time Up and Go Test - TUG | 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 Short Form - 36 Quality of Life Test - SF 36 | 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 | 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 Lower Extremity Isokinetic Dynamometry | pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] |
| Change in the Visual Analogic Scale - VAS | 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 Brazilian version of the McGill Pain Questionnaire | 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 | 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 Conditioned Pain Modulation - CPM | 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 Pain-Related Self-Statements Scale - Catastrophizing Subscale (PRSS-Catastrophizing) | 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 | 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 | 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 | 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 | 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) | pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] |
| Change in the Electroencephalography | pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] |
| D014947 | Wounds and Injuries |