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

University of Sao Paulo General Hospital

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: Outpatient active group; Device: Outpatient placebo group; Device: Inpatient placebo group; Device: Inpatient active group

Study type: Interventional

Funder types: Other

Identifiers

NCT02562001

43450715.7.0000.0068_CAAE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 4 patient groups

Outpatient active group

Experimental group

Description:

This group will receive active tDCS, combined with Lokomat gait training

Treatment:

Device: Outpatient active group

Inpatient active group

Experimental group

Description:

This group will receive active tDCS, combined with Lokomat gait training

Treatment:

Device: Inpatient active group

Outpatient placebo group

Experimental group

Description:

This group will receive placebo tDCS, combined with Lokomat gait training

Treatment:

Device: Outpatient placebo group

Inpatient placebo group

Experimental group

Description:

This group will receive placebo tDCS, combined with Lokomat gait training

Treatment:

Device: Inpatient placebo group