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

NCT ID: NCT02562001

Last Updated: 2021-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-06
• Study Completion Date: 2018-05-05

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.

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Outpatient active group

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

Group Type: EXPERIMENTAL

Outpatient active group

Intervention Type: DEVICE

active tDCS during 20 minutes before Lokomat training for outpatients

Inpatient active group

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

Group Type: EXPERIMENTAL

Inpatient active group

Intervention Type: DEVICE

active tDCS during 20 minutes before Lokomat training for inpatients

Outpatient placebo group

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

Group Type: EXPERIMENTAL

Outpatient placebo group

Intervention Type: DEVICE

placebo tDCS during 20 minutes before Lokomat training for outpatients

Inpatient placebo group

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

Group Type: EXPERIMENTAL

Inpatient placebo group

Intervention Type: DEVICE

placebo tDCS during 20 minutes before Lokomat training for inpatients

Interventions

Outpatient active group

active tDCS during 20 minutes before Lokomat training for outpatients

Intervention Type: DEVICE

Outpatient placebo group

placebo tDCS during 20 minutes before Lokomat training for outpatients

Intervention Type: DEVICE

Inpatient active group

active tDCS during 20 minutes before Lokomat training for inpatients

Intervention Type: DEVICE

Inpatient placebo group

placebo tDCS during 20 minutes before Lokomat training for inpatients

Intervention Type: DEVICE

Other Intervention Names

tDCS active; tDCS placebo; tDCS active; tDCS placebo

Eligibility Criteria

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;

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Linamara Rizzo Battistella, MD PhD

Professor of the Medical School, USP; Chairman of the Board of Medical and Physical Rehabilitation Institute (IMREA)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linamara Battistella, Md PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 30295660 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32540720 (View on PubMed)

Other Identifiers

43450715.7.0000.0068_CAAE

Identifier Type: -

Identifier Source: org_study_id