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

NCT02562001 | Completed

• 1 other identifier: 43450715.7.0000.0068_CAAE
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injuries; gait training; robotic; Lokomat; Transcranial Magnetic Stimulation; transcranial direct-current stimulation; Electroencephalography; Functional near-infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• 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]

Study Arms (4)

Outpatient active group

EXPERIMENTAL

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

Device: Outpatient active group

Inpatient active group

EXPERIMENTAL

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

Device: Inpatient active group

Outpatient placebo group

EXPERIMENTAL

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

Device: Outpatient placebo group

Inpatient placebo group

EXPERIMENTAL

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

Device: Inpatient placebo group

Interventions

Outpatient active group DEVICE

active tDCS during 20 minutes before Lokomat training for outpatients

Also known as: tDCS active

Outpatient active group

Outpatient placebo group DEVICE

placebo tDCS during 20 minutes before Lokomat training for outpatients

Also known as: tDCS placebo

Outpatient placebo group

Inpatient active group DEVICE

active tDCS during 20 minutes before Lokomat training for inpatients

Also known as: tDCS active

Inpatient active group

Inpatient placebo group DEVICE

placebo tDCS during 20 minutes before Lokomat training for inpatients

Also known as: tDCS placebo

Inpatient placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and radiological diagnosis of incomplete spinal cord injury of traumatic origin;
• 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.

You may not qualify if:

• 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;
• 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.
• 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).

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo

São Paulo, 04116-030, Brazil

Location

Related 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):58495. doi: 10.3791/58495.

  PMID: 30295660 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.

  PMID: 32540720 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Linamara Battistella, Md PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Medical School, USP; Chairman of the Board of Medical and Physical Rehabilitation Institute (IMREA)

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: September 29, 2015
• Study Start: May 6, 2015
• Primary Completion: May 5, 2018
• Study Completion: May 5, 2018
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

BR (1)