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

Primary Purpose

Spinal Cord Injuries

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Outpatient active group

Outpatient placebo group

Inpatient active group

Inpatient placebo group

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injuries, gait training, robotic, Lokomat, Transcranial Magnetic Stimulation, transcranial direct-current stimulation, Electroencephalography, Functional near-infrared spectroscopy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Outpatient active group

Inpatient active group

Outpatient placebo group

Inpatient placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

A. Change in the Walk Index for Spinal Cord Injury, WISCI II

Secondary Outcome Measures

American Spinal Injury Association Impairment Scale - ASIA

Change in the (Wechsler Adult Intelligence Scale - WASI 2014)

Change in the Ashworth Modified Scale

Change in the Berg Balance Test

Change in the 10 meters Walking Test and 6 Minutes Walking test

Change in the Time Up and Go Test - TUG

Change in the Short Form - 36 Quality of Life Test - SF 36

Change in the Spinal Cord Independence Measure - SCIM

Change in the Lower Extremity Isokinetic Dynamometry

Change in the Visual Analogic Scale - VAS

Change in the Brazilian version of the McGill Pain Questionnaire

Change in the Pressure Algometer

Change in the Conditioned Pain Modulation - CPM

Change in the Pain-Related Self-Statements Scale - Catastrophizing Subscale (PRSS-Catastrophizing)

Change in the Hospital Anxiety and Depression Scale - HAD

Change in the Beck Depression Inventory

Change in the Patient Health Questionnaire 9 - PHQ 9

Change in the Transcranial Magnetic Stimulation

Change in the Functional Near-Infrared Spectroscopy - fNIRS 16 optodes (48 channels)

Change in the Electroencephalography

Full Information

NCT ID

NCT02562001

First Posted

July 30, 2015

Last Updated

June 2, 2021

Sponsor

University of Sao Paulo General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02562001

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

May 6, 2015 (Actual)

Primary Completion Date

May 5, 2018 (Actual)

Study Completion Date

May 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Outpatient active group

Arm Type

Experimental

Arm Description

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

Arm Title

Inpatient active group

Arm Type

Experimental

Arm Description

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

Arm Title

Outpatient placebo group

Arm Type

Experimental

Arm Description

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

Arm Title

Inpatient placebo group

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Outpatient active group

Other Intervention Name(s)

tDCS active

Intervention Description

active tDCS during 20 minutes before Lokomat training for outpatients

Intervention Type

Device

Intervention Name(s)

Outpatient placebo group

Other Intervention Name(s)

tDCS placebo

Intervention Description

placebo tDCS during 20 minutes before Lokomat training for outpatients

Intervention Type

Device

Intervention Name(s)

Inpatient active group

Other Intervention Name(s)

tDCS active

Intervention Description

active tDCS during 20 minutes before Lokomat training for inpatients

Intervention Type

Device

Intervention Name(s)

Inpatient placebo group

Other Intervention Name(s)

tDCS placebo

Intervention Description

placebo tDCS during 20 minutes before Lokomat training for inpatients

Primary Outcome Measure Information:

Title

A. Change in the Walk Index for Spinal Cord Injury, WISCI II

Time Frame

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 Measure Information:

Title

American Spinal Injury Association Impairment Scale - ASIA

Time Frame

pre (before treatment) [t0]

Title

Change in the (Wechsler Adult Intelligence Scale - WASI 2014)

Time Frame

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]

Title

Change in the Ashworth Modified Scale

Time Frame

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]

Title

Change in the Berg Balance Test

Time Frame

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]

Title

Change in the 10 meters Walking Test and 6 Minutes Walking test

Time Frame

Title

Change in the Time Up and Go Test - TUG

Time Frame

Title

Change in the Short Form - 36 Quality of Life Test - SF 36

Time Frame

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]

Title

Change in the Spinal Cord Independence Measure - SCIM

Time Frame

Title

Change in the Lower Extremity Isokinetic Dynamometry

Time Frame

pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]

Title

Change in the Visual Analogic Scale - VAS

Time Frame

Title

Change in the Brazilian version of the McGill Pain Questionnaire

Time Frame

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]

Title

Change in the Pressure Algometer

Time Frame

Title

Change in the Conditioned Pain Modulation - CPM

Time Frame

Title

Change in the Pain-Related Self-Statements Scale - Catastrophizing Subscale (PRSS-Catastrophizing)

Time Frame

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]

Title

Change in the Hospital Anxiety and Depression Scale - HAD

Time Frame

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]

Title

Change in the Beck Depression Inventory

Time Frame

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]

Title

Change in the Patient Health Questionnaire 9 - PHQ 9

Time Frame

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]

Title

Change in the Transcranial Magnetic Stimulation

Time Frame

pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]

Title

Change in the Functional Near-Infrared Spectroscopy - fNIRS 16 optodes (48 channels)

Time Frame

pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]

Title

Change in the Electroencephalography

Time Frame

pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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; 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linamara Battistella, Md PhD

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

São Paulo

ZIP/Postal Code

04116-030

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

30295660

Citation

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.

Results Reference

result

PubMed Identifier

32540720

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. doi: 10.1016/j.clinph.2020.04.166. Epub 2020 May 22.

Results Reference

result

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

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