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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Outpatient active group; Device: Inpatient active group; Device: Outpatient placebo group; Device: Inpatient placebo group

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 04116-030
    • Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Outpatient active group; This group will receive active tDCS, combined with Lokomat gait training	Device: Outpatient active group; active tDCS during 20 minutes before Lokomat training for outpatients; Other Names: tDCS active
Experimental: Inpatient active group; This group will receive active tDCS, combined with Lokomat gait training	Device: Inpatient active group; active tDCS during 20 minutes before Lokomat training for inpatients; Other Names: tDCS active
Experimental: Outpatient placebo group; This group will receive placebo tDCS, combined with Lokomat gait training	Device: Outpatient placebo group; placebo tDCS during 20 minutes before Lokomat training for outpatients; Other Names: tDCS placebo
Experimental: Inpatient placebo group; This group will receive placebo tDCS, combined with Lokomat gait training	Device: Inpatient placebo group; placebo tDCS during 20 minutes before Lokomat training for inpatients; Other Names: tDCS placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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]

Secondary Outcome Measures

Outcome Measure	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]
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]

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Linamara Battistella, Md PhD, University of Sao Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2015
• Primary Completion (Actual): May 5, 2018
• Study Completion (Actual): May 5, 2018

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 29, 2015

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Transcranial Magnetic Stimulation; robotic; Electroencephalography; Lokomat; Spinal Cord Injuries; Functional near-infrared spectroscopy; gait training; transcranial direct-current stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 43450715.7.0000.0068_CAAE