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

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ClinicalTrials.gov Identifier: NCT02562001
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
Linamara Rizzo Battistella, MD PhD, University of Sao Paulo General Hospital

July 30, 2015
September 29, 2015
November 27, 2017
November 2015
June 2018   (Final data collection date for primary outcome measure)
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] ]
Change in the Walk Index for Spinal Cord Injury, WISCI [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
Complete list of historical versions of study NCT02562001 on ClinicalTrials.gov Archive Site
  • American Spinal Injury Association Impairment Scale - ASIA [ Time Frame: pre (before treatment) [t0] ]
  • 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] ]
  • 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] ]
  • 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] ]
  • Change in the 10 meters Walking Test and 6 Minutes Walking 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] ]
  • Change in the Time Up and Go Test - TUG [ 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] ]
  • 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] ]
  • Change in the Spinal Cord Independence Measure - SCIM [ 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] ]
  • 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] ]
  • Change in the Visual Analogic Scale - VAS [ 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] ]
  • 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] ]
  • Change in the Pressure Algometer [ 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] ]
  • Change in the Conditioned Pain Modulation - CPM [ 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] ]
  • 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] ]
  • 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] ]
  • 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] ]
  • 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] ]
  • Change in the Transcranial Magnetic Stimulation [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] ]
  • Change in the Functional Near-Infrared Spectroscopy - fNIRS 16 channels [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] ]
  • Change in the Electroencephalography [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] ]
  • Change in the American Spinal Injury Association Impairment Scale [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the Mini-mental State Examination [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the Ashworth Modified Scale [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the Berg Balance Test [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the 10 meters Walking Test and 6 Minutes Walking test [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the Short Form - 36 Quality of Life Test [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the Spinal Cord Independence Measure [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the Bowel Function Basic Data Set - Internacional Spinal Cord Society [ Time Frame: pre (before), post (after) and 3 months follow up ]
  • Change in the Quality Of Life Basic Data Set - Internacional Spinal Cord Society [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the International Spinal Cord Injury Upper Extremity Basic Data Set Form - Internacional Spinal Cord Society [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the Visual Analogic Scale [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the Brazilian version of the McGill Pain Questionnaire [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the pressure algometer [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the International Spinal Cord Injury Pain Basic Data Set [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the Transcranial Magnetic Stimulation [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the NIRS 8channel w. Full Brainsight Neuronavigation System [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
  • Change in the Electroencephalogram [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 6 weeks] and 3 months follow up [after 18 weeks] ]
Not Provided
Not Provided
 
Association Between tDCS and Lokomat Training in Patients With Incomplete Spinal Cord Injury
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
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Spinal Cord Injuries
  • Device: Outpatient active group
    active tDCS during 20 minutes before Lokomat training for outpatients
    Other Name: tDCS active
  • Device: Outpatient placebo group
    placebo tDCS during 20 minutes before Lokomat training for outpatients
    Other Name: tDCS placebo
  • Device: Inpatient active group
    active tDCS during 20 minutes before Lokomat training for inpatients
    Other Name: tDCS active
  • Device: Inpatient placebo group
    placebo tDCS during 20 minutes before Lokomat training for inpatients
    Other Name: tDCS placebo
  • Experimental: Outpatient active group
    This group will receive active tDCS, combined with Lokomat gait training
    Intervention: Device: Outpatient active group
  • Experimental: Inpatient active group
    This group will receive active tDCS, combined with Lokomat gait training
    Intervention: Device: Inpatient active group
  • Experimental: Outpatient placebo group
    This group will receive placebo tDCS, combined with Lokomat gait training
    Intervention: Device: Outpatient placebo group
  • Experimental: Inpatient placebo group
    This group will receive placebo tDCS, combined with Lokomat gait training
    Intervention: Device: Inpatient placebo group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
20
November 2018
June 2018   (Final data collection date for primary outcome measure)

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).

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact: Marcel Simis, Md PhD +55 11 5180-7897 centrodepesquisa.imrea@hc.fm.usp.br
Brazil
 
 
NCT02562001
43450715.7.0000.0068_CAAE
No
Not Provided
Not Provided
Linamara Rizzo Battistella, MD PhD, University of Sao Paulo General Hospital
University of Sao Paulo General Hospital
Not Provided
Principal Investigator: Linamara Battistella, Md PhD University of Sao Paulo
University of Sao Paulo General Hospital
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP