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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

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Outpatient active group Device: Outpatient placebo group Device: Inpatient active group Device: Inpatient placebo group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Outpatient active group
This group will receive active tDCS, combined with Lokomat gait training
Device: Outpatient active group
active tDCS during 20 minutes before Lokomat training for outpatients
Other Name: tDCS active

Experimental: Inpatient active group
This group will receive active tDCS, combined with Lokomat gait training
Device: Inpatient active group
active tDCS during 20 minutes before Lokomat training for inpatients
Other Name: tDCS active

Experimental: Outpatient placebo group
This group will receive placebo tDCS, combined with Lokomat gait training
Device: Outpatient placebo group
placebo tDCS during 20 minutes before Lokomat training for outpatients
Other Name: tDCS placebo

Experimental: Inpatient placebo group
This group will receive placebo tDCS, combined with Lokomat gait training
Device: Inpatient placebo group
placebo tDCS during 20 minutes before Lokomat training for inpatients
Other Name: tDCS placebo




Primary Outcome Measures :
  1. 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 Measures :
  1. American Spinal Injury Association Impairment Scale - ASIA [ Time Frame: pre (before treatment) [t0] ]
  2. 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] ]
  3. 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] ]
  4. 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] ]
  5. 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] ]
  6. 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] ]
  7. 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] ]
  8. 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] ]
  9. 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] ]
  10. 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] ]
  11. 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] ]
  12. 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] ]
  13. 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] ]
  14. 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] ]
  15. 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] ]
  16. 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] ]
  17. 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] ]
  18. Change in the Transcranial Magnetic Stimulation [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] ]
  19. 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] ]
  20. Change in the Electroencephalography [ Time Frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562001


Contacts
Contact: Marcel Simis, Md PhD +55 11 5180-7897 centrodepesquisa.imrea@hc.fm.usp.br

Locations
Brazil
Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, Brazil, 04116-030
Contact: Marcel Simis, MD    55-11-5180-7897    marcel.simis@hc.fm.usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Linamara Battistella, Md PhD University of Sao Paulo

Responsible Party: Linamara Rizzo Battistella, MD PhD, Professor of the Medical School, USP; Chairman of the Board of Medical and Physical Rehabilitation Institute (IMREA), University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02562001     History of Changes
Other Study ID Numbers: 43450715.7.0000.0068_CAAE
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017

Keywords provided by Linamara Rizzo Battistella, MD PhD, University of Sao Paulo General Hospital:
Spinal Cord Injuries
gait training
robotic
Lokomat
Transcranial Magnetic Stimulation
transcranial direct-current stimulation
Electroencephalography
Functional near-infrared spectroscopy

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System