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

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562001
• Other study ID #: 43450715.7.0000.0068_CAAE
• Status: Completed
• Phase: N/A
• Start date: May 6, 2015
• Est. completion date: May 5, 2018

Study information

• Verified date: June 2021
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 5, 2018
• Est. primary completion date: May 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Outpatient active group
active tDCS during 20 minutes before Lokomat training for outpatients
• Outpatient placebo group
placebo tDCS during 20 minutes before Lokomat training for outpatients
• Inpatient active group
active tDCS during 20 minutes before Lokomat training for inpatients
• Inpatient placebo group
placebo tDCS during 20 minutes before Lokomat training for inpatients

Locations

Country	Name	City	State
Brazil	Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

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). doi: 10.3791/58495. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	American Spinal Injury Association Impairment Scale - ASIA		pre (before treatment) [t0]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	Change in the Lower Extremity Isokinetic Dynamometry		pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	Change in the Transcranial Magnetic Stimulation		pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Secondary	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]
Secondary	Change in the Electroencephalography		pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]